ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS 530050 / 530100Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00015482530501), received between Apr 30, 2019 and Apr 16, 2024 — classified as 28 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Low Readings” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2024Low Readings; Low Readings

  CVP1AV34079. LOT WL11BBAJA - 2025-08-01 - 100CT. CALLER HAS A DEXCOM, AND THE CLASSIC METER IS READING HIGH COMPARED TO THE DEXCOM AND HER TRU METRIX METER THAT SHE HAS. CALLER RECEIVED A READING ON CLASSIC ON (B)(6) 2024 AT 12:53 PM AND THE READING WAS 359, AND SHE RECEIVED A READING ON TRU METRIX ON (B)(6) 2024 AT 12:55 PM AND IT WAS 71. CUSTOMER DID NOT REPORT ANY ADVERSE EVENT ISSUES FROM THESE READINGS. CALLER DID NOT GIVE ANY RESULT EXAMPLES FROM THE DEXCOM. THE COMPARED READINGS OF 359 AND 71 ARE OUTSIDE ZONES A & B AND THIS WOULD BE CONSIDERED A MALFUNCTION AND REPORTABLE. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND SENT RETURN LABEL.

  Patient problems: Insufficient Information

  MAUDE report 19122707 ↗
• InjuryApr 16, 2024Low Readings; Low Readings

  CVP1AV34079. LOT WL11BBAJA - 2025-08-01 - 100CT. CALLER HAS A DEXCOM, AND THE CLASSIC METER IS READING HIGH COMPARED TO THE DEXCOM AND HER TRU METRIX METER THAT SHE HAS. CALLER RECEIVED A READING ON CLASSIC ON 1/12/2024 AT 12:53 PM AND THE READING WAS 359, AND SHE RECEIVED A READING ON TRU METRIX ON 1/12/2024 AT 12:55 PM AND IT WAS 71. CUSTOMER DID NOT REPORT ANY ADVERSE EVENT ISSUES FROM THESE READINGS. CALLER DID NOT GIVE ANY RESULT EXAMPLES FROM THE DEXCOM. THE COMPARED READINGS OF 359 AND 71 ARE OUTSIDE ZONES A & B AND THIS WOULD BE CONSIDERED A MALFUNCTION AND REPORTABLE. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia

  MAUDE report 19122706 ↗
• InjuryMar 26, 2024Low Readings; Low Readings

  CUSTOMER HAD SENT AN EMAIL STATING THAT THE GLUCOSE MONITORS ARE READING SEVERAL POINTS OFF FROM THE HOSPITAL READINGS. WHEN THIS BEGINS TO HAPPEN (AFTER ABOUT SIX MONTHS OF USE) WE END UP REPLACING THEM. AS RECENTLY AS LAST WEEK, WE HAD A READING OF 300, OUR LOCAL FIRE DEPARTMENT HAD A READING OF 500, AND THE HOSPITAL OBTAINED A READING OF 1100. THIS WAS A CRITICAL PATIENT IN DIABETIC KETOACIDOSIS WHO REQUIRED INTUBATION. ARKRAY FOLLOWED UP WITH CUSTOMER BY PHONE. VERIFIED THE READINGS WERE WITHIN 20 MINUTES OF EACH OTHER. CUSTOMER STORES METER AND TEST STRIPS TOGETHER IN THE AMBULANCE IN A MEDICAL BAG IN THE BACK OF THE AMBULANCE. METERS ARE STORED IN A TEMPERATURE-CONTROLLED ENVIRONMENT OF 68-72 DEGREES. CUSTOMER SAID THAT THE INCIDENT OCCURRED ON (B)(6) 2024 AT ABOUT 10:33 PM. THEY RECEIVED A CALL THAT A PATIENT WAS UNRESPONSIVE. EMS ARRIVED AT THE PATIENT'S HOME, TOOK HER GLUCOSE READING AND GAVE HER OXYGEN. PATIENT TAKES NOVOLOG AND VICTOZA FOR TYPE 2 DIABETES. SHE DOESN'T USE OXYGEN NORMALLY BUT WAS GIVEN OXYGEN UPON ARRIVAL AT HER HOME. VERIFIED THAT CUSTOMER SEALS THE TEST STRIP BOTTLE IMMEDIATELY AFTER REMOVING A STRIP. VERIFIED THEY USED ALCOHOL TO CLEAN THE PATIENT'S FI

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 18984391 ↗
• InjuryDec 14, 2023Low Readings; Low Readings

  THE CALLER REPORTED THAT A METER WAS READING LOW. THE CALLER STATED THAT HE WAS NOT THERE WHEN THE INCIDENT HAPPENED, BUT HIS TEAM WAS THERE. THE CALLER STATED THAT WHEN HIS TEAM USED THE ASSURE PRISM ON THE PATIENT, THEY RECEIVED A READING OF 221 AT 1:44 AM ON (B)(6) 2023. THE CALLER STATED THAT WHEN THEY TOOK THE PATIENT TO THE HOSPITAL, THE LAB WORK ON THE PATIENT STATED THEIR BLOOD GLUCOSE WAS 600. THE CALLER STATED THAT IT WAS 10 TO 15 MINUTES BETWEEN WHEN THEY TOOK THE PATIENT'S BLOOD SUGAR WITH THE METER AND DOING LAB WORK ON THE PATIENT. THE CALLER STATED THAT HE DOES NOT KNOW WHAT THE READING WAS FOR THE CONTROL SOLUTION, BUT THE CONTROL SOLUTION READING WAS IN RANGE. REPLACED METER, STRIPS AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia

  MAUDE report 18332360 ↗
• InjuryNov 20, 2023Low Readings; Low Readings

  THE CALLER REPORTED THAT A METER WAS READING LOW. THE CALLER STATED THAT HE WAS NOT THERE WHEN THE INCIDENT HAPPENED, BUT HIS TEAM WAS THERE. THE CALLER STATED THAT WHEN HIS TEAM USED THE ASSURE PRISM ON THE PATIENT, THEY RECEIVED A READING OF 221 AT 1:44 AM ON (B)(6) 2023. THE CALLER STATED THAT WHEN THEY TOOK THE PATIENT TO THE HOSPITAL, THE LAB WORK ON THE PATIENT STATED THEIR BLOOD GLUCOSE WAS 600. THE CALLER STATED THAT IT WAS 10 TO 15 MINUTES BETWEEN WHEN THEY TOOK THE PATIENT'S BLOOD SUGAR WITH THE METER AND DOING LAB WORK ON THE PATIENT. THE CALLER STATED THAT HE DOES NOT KNOW WHAT THE READING WAS FOR THE CONTROL SOLUTION, BUT THE CONTROL SOLUTION READING WAS IN RANGE. REPLACED METER, STRIPS AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia

  MAUDE report 18170637 ↗
• InjuryJul 20, 2023Low Readings; Low Readings

  ON (B)(6), 2023, FRANKLIN COMMUNITY FIRE DEPARTMENT RECEIVED A CALL FOR CHEST PAINS. UPON ARRIVAL, PATIENT WAS CONSCIOUS, AND SHE WAS EXHIBITING SIGNS OF LOW BLOOD GLUCOSE. THE FIRE DEPARTMENT DID A BLOOD GLUCOSE TEST WITH THE ASSURE PRISM METER AND RECEIVED A READING OF 31. FIRE DEPARTMENT PERSONNEL HAD HER EAT A PEANUT BUTTER AND JELLY SANDWICH AND DRINK SOME SWEET TEA. THEY CHECKED HER BLOOD GLUCOSE AGAIN 10 MINUTES LATER WITH THE ASSURE PRISM METER AND THE READING WAS 32, WHICH SEEMED UNUSUAL. THE EMS CREW ARRIVED TO TAKE OVER THE SITUATION, AND WHEN THEY TESTED THE PATIENT'S BLOOD GLUCOSE WITH THEIR METER, THE READING WAS 480. THE FIRE DEPARTMENT LEFT, AND EMS PERSONNEL TRANSPORTED PATIENT TO THE HOSPITAL WHERE IT IS UNKNOWN WHAT KIND OF TREATMENT SHE RECEIVED. WHEN CALLER RETURNED TO THE FIRE DEPARTMENT AFTER THE CALL, THE CALLER PERFORMED A BLOOD GLUCOSE TEST ON HIMSELF WITH THE ASSURE PRISM AND RECEIVED A READING OF 41. CALLER PERFORMED A CONTROL SOLUTION TEST WITH THE ASSURE PRISM USING L2 CONTROL SOLUTION AND RECEIVED A READING OF 31 AND THE RANGE FOR THE L2 CONTROL SOLUTION WAS 31, INDICATING THE METER WAS STILL READING LOW, EVEN WITH CONTROL SOLUTION. THE SAME CONTROL S

  Patient problems: Chest Pain; Hyperglycemia

  MAUDE report 17359001 ↗
• InjuryJul 13, 2023Low Readings; Low Readings

  ON (B)(6) 2023, (B)(6) FIRE DEPARTMENT RECEIVED A CALL FOR CHEST PAINS. UPON ARRIVAL, PATIENT WAS CONSCIOUS, AND SHE WAS EXHIBITING SIGNS OF LOW BLOOD GLUCOSE. THE FIRE DEPARTMENT DID A BLOOD GLUCOSE TEST WITH THE ASSURE PRISM METER AND RECEIVED A READING OF 31. FIRE DEPARTMENT PERSONNEL HAD HER EAT A PEANUT BUTTER AND JELLY SANDWICH AND DRINK SOME SWEET TEA. THEY CHECKED HER BLOOD GLUCOSE AGAIN 10 MINUTES LATER WITH THE ASSURE PRISM METER AND THE READING WAS 32, WHICH SEEMED UNUSUAL. THE EMS CREW ARRIVED TO TAKE OVER THE SITUATION, AND WHEN THEY TESTED THE PATIENT'S BLOOD GLUCOSE WITH THEIR METER, THE READING WAS 480. THE FIRE DEPARTMENT LEFT, AND EMS PERSONNEL TRANSPORTED PATIENT TO THE HOSPITAL WHERE IT IS UNKNOWN WHAT KIND OF TREATMENT SHE RECEIVED. WHEN CALLER RETURNED TO THE FIRE DEPARTMENT AFTER THE CALL, THE CALLER PERFORMED A BLOOD GLUCOSE TEST ON HIMSELF WITH THE ASSURE PRISM AND RECEIVED A READING OF 41. CALLER PERFORMED A CONTROL SOLUTION TEST WITH THE ASSURE PRISM USING L2 CONTROL SOLUTION AND RECEIVED A READING OF 31 AND THE RANGE FOR THE L2 CONTROL SOLUTION WAS 31, INDICATING THE METER WAS STILL READING LOW, EVEN WITH CONTROL SOLUTION. THE SAME CONTROL SOLUTION WAS U

  Patient problems: Chest Pain; Hyperglycemia

  MAUDE report 17316303 ↗
• InjuryApr 5, 2023Low Readings; Low Readings

  PATIENT TESTED HI ON THEIR OWN PERSONAL METER. PATIENT WAS VOMITING DUE TO HIGH BLOOD GLUCOSE. PARAMEDICS WERE CALLED. PATIENT WAS PICKED UP BY PARAMEDICS ON (B)(6) 2023 AT 8:37 AM. WHEN THE PARAMEDICS ARRIVED, THEY TESTED THE PATIENT WITH THE ASSURE PRISM METER AND RECEIVED A READING OF 350. THEY DID NOT TREAT THE PATIENT BASED ON THIS READING BECAUSE THEY WERE UNSURE IF THE METER WAS READING CORRECTLY. PARAMEDICS TRANSFERRED PATIENT TO HOSPITAL. PATIENT WAS TESTED THERE, WITH THEIR METER, AND THEY RECEIVED A READING OF 570. THE TREATMENT THAT HOSPITAL PROVIDED IS UNKNOWN. REPLACED METER, STRIPS, AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 16687153 ↗
• InjuryMar 16, 2023Low Readings; Low Readings

  PATIENT TESTED HI ON THEIR OWN PERSONAL METER. PATIENT WAS VOMITING DUE TO HIGH BLOOD GLUCOSE. PARAMEDICS WERE CALLED. PATIENT WAS PICKED UP BY PARAMEDICS ON (B)(6) 2023 AT 8:37 AM. WHEN THE PARAMEDICS ARRIVED, THEY TESTED THE PATIENT WITH THE ASSURE PRISM METER AND RECEIVED A READING OF 350. THEY DID NOT TREAT THE PATIENT BASED ON THIS READING BECAUSE THEY WERE UNSURE IF THE METER WAS READING CORRECTLY. PARAMEDICS TRANSFERRED PATIENT TO HOSPITAL. PATIENT WAS TESTED THERE, WITH THEIR METER, AND THEY RECEIVED A READING OF 570. THE TREATMENT THAT HOSPITAL PROVIDED IS UNKNOWN. REPLACED METER, STRIPS, AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 16552942 ↗
• InjuryFeb 10, 2023High Readings; High Readings

  THEY HAVE BEEN HAVING ISSUES WITH THESE GLUCOMETERS. THEY HAVE HAD THREE OCCURRENCES IN THE PAST FEW WEEKS WHERE THE READINGS HAVE BEEN OFF. REPORTER WAS ON ONE CALL WHERE THE PATIENT'S FREE STYLE LIBRE READ 55 AND THE PRISM READ 98. THEY RE-CHECKED AFTER THEY STARTED AN IV AND THE PRISM READ 102. AFTER ARRIVAL TO THE HOSPITAL, THEY CHECKED AGAIN, AND IT WAS NOW 33 ON ANOTHER METER. THEY SWAPPED TO A DIFFERENT MONITOR ON THAT AMBULANCE.

  Patient problems: Hypoglycemia

  MAUDE report 16348906 ↗
• MalfunctionFeb 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER HAS BEEN HAVING ISSUES WITH THESE GLUCOMETERS. THEY STATED THEY HAVE HAD THREE OCCURRENCES IN THE PAST FEW WEEKS WHERE THE READINGS HAVE BEEN OFF. THEY RECEIVED A CALL FOR PATIENT EXPERIENCING DIABETIC PROBLEMS. HE HAD FALLEN. HE WAS ALERT BUT CONFUSED. THE PATIENT'S SON HAD GIVEN HONEY BEFORE THE AMBULANCE ARRIVED. THEY CHECKED THE PATIENT'S SUGAR. THEY RECEIVED A READING OF 155. THE PARAMEDICS GAVE HIM GLUCOSE GEL, FOOD (SANDWICH) AND JUICE. THEY CHECKED HIM AGAIN AND THE METER READ 90, WHICH THEY FEEL WAS INCORRECT AND SHOULD HAVE BEEN HIGHER AFTER THE HONEY, THE GLUCOSE GEL, SO THEY THINK THE METER READ TOO HIGH WHEN HE WAS ORIGINALLY TESTED, AND HE WAS LOW. THE PATIENT BECAME ALERT, AND HE WAS ABLE TO ANSWER ALL THEIR QUESTIONS. HE CAME BACK TO NORMAL. HE WAS NOT TRANSPORTED TO THE HOSPITAL. VERIFIED THEY CHANGE THE LANCETS EACH TIME THEY TEST. THEY USE ALCOHOL TO CLEAN FINGERS AND ALLOW FINGER TO DRY COMPLETELY. PATIENT WAS NOT RECEIVING ANY OXYGEN THERAPY. PATIENT DOESN'T HAVE TROUBLE GETTING A BLOOD SAMPLE. THE METER AND TEST STRIPS ARE STORED TOGETHER IN THE BACK OF THE AMBULANCE IN A TEMPERATURE-CONTROLLED ENVIRONMENT. REPLACED METER, STRIPS AND SENT RETURN LABEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344008 ↗
• InjuryJul 28, 2022Incorrect Measurement; Incorrect Measurement

  CALLER STATED THEY HAVE BEEN HAVING REPEATED ISSUES WITH RECEIVING FALSELY LOW AND FALSELY HIGH NUMBERS FROM THE METERS. CALLER STATED THEY HAD A COUPLE SITUATIONS WHERE FOR EXAMPLE THE ASSURE PRISM WOULD READ 300, BUT THE HOSPITAL READINGS WOULD BE 600, 700, OR 900. CALLER ALSO GAVE AN EXAMPLE WHERE THE ASSURE PRISM METER WOULD READ 120, BUT THE HOSPITAL READING WAS 37. CALLER STATED THEY HAVE PULLED THE ASSURE PRISM METERS FROM SERVICE. CALLER STATED THEY HAVE PERFORMED MULTIPLE CONTROL SOLUTION TESTS AND THEY ARE ALL IN RANGE. REP THEN GATHERED CALLER'S FACILITY NAME, ADDRESS, PHONE NUMBER. REP QUESTIONED CALLER ABOUT DETAILS OF TIME WHEN READING WAS TAKEN, AND CALLER WASN'T EXACTLY SURE OF THE DETAILS AT THE TIME OF THE READING. CALLER THEN INFORMED REP THAT A METER HAD READINGS OF 120 AND 128 THAT WERE FIVE MINUTES APART. THIS WAS A KNOWN DIABETIC PATIENT THEY WERE FAMILIAR WITH WHO WAS HAVING A DIABETIC ISSUE. IT WAS NOTED DURING THE CALL THAT THAT THE PATIENT HADN'T TAKEN ANY MEDICATIONS. READINGS WERE RECEIVED AROUND 11:51 AND THE PATIENT ARRIVED AT THE HOSPITAL AT 12:11 AND THE HOSPITAL RECEIVED A READING OF 37. CALLER WAS UNSURE IF THE HOSPITAL READING WAS VENOUS OR CAPIL

  Patient problems: Hypoglycemia

  MAUDE report 15119586 ↗
• InjuryJul 28, 2022Incorrect Measurement; Incorrect Measurement

  CALLER STATED THEY HAVE BEEN HAVING REPEATED ISSUES WITH RECEIVING FALSELY LOW AND FALSELY HIGH NUMBERS FROM THE METERS. CALLER STATED THEY HAD A COUPLE SITUATIONS WHERE FOR EXAMPLE THE ASSURE PRISM WOULD READ 300, BUT THE HOSPITAL READINGS WOULD BE 600, 700, OR 900. CALLER ALSO GAVE AN EXAMPLE WHERE THE ASSURE PRISM METER WOULD READ 120, BUT THE HOSPITAL READING WAS 37. CALLER STATED THEY HAVE PULLED THE ASSURE PRISM METERS FROM SERVICE. CALLER STATED THEY HAVE PERFORMED MULTIPLE CONTROL SOLUTION TESTS AND THEY ARE ALL IN RANGE. REP THEN GATHERED CALLER'S FACILITY NAME, ADDRESS, PHONE NUMBER. REP QUESTIONED CALLER ABOUT DETAILS OF TIME WHEN READING WAS TAKEN, AND CALLER WASN'T EXACTLY SURE OF THE DETAILS AT THE TIME OF THE READING. CALLER THEN INFORMED REP THAT A METER HAD READINGS OF 120 AND 128 THAT WERE FIVE MINUTES APART. THIS WAS A KNOWN DIABETIC PATIENT THEY WERE FAMILIAR WITH WHO WAS HAVING A DIABETIC ISSUE. IT WAS NOTED DURING THE CALL THAT THAT THE PATIENT HADN'T TAKEN ANY MEDICATIONS. READINGS WERE RECEIVED AROUND 11:51 AND THE PATIENT ARRIVED AT THE HOSPITAL AT 12:11 AND THE HOSPITAL RECEIVED A READING OF 37. CALLER WAS UNSURE IF THE HOSPITAL READING WAS VENOUS OR CAPIL

  Patient problems: Hypoglycemia

  MAUDE report 15119585 ↗
• InjuryJul 28, 2022High Readings; High Readings

  ON PATIENT, CUSTOMER RECEIVED READING OF 244 WHICH SEEMED HIGH TO CUSTOMER, SO THEY HAD "RESCUE" (AFTER FURTHER LISTENING THIS IS PRESUMED TO BE THE FIRE DEPARTMENT) CHECK THE PATIENT WITH THEIR MONITOR, AND IT READ 180. "RESCUE" ENDED UP TAKING THE PATIENT TO THE HOSPITAL. AT THE HOSPITAL THE READING WAS 178. THIS ALL OCCURRED WITH 20 MINUTES, SO CALLER STATED THE PATIENT COULDN'T HAVE BURNED THAT MUCH SUGAR. CALLER IS CONCERNED THAT THEY WILL UNDERTREAT OR OVERTREAT IF THE READINGS ON THE METERS AREN'T CORRECT. CALLER STATED THEY JUST STARTED USING THE ASSURE PRISM METER SYSTEM. REP THEN CHECKED VARIANCE OF NUMBERS. VARIANCE IS 26-27%AND READINGS ARE ALL IN ZONE A. REP THEN OFFERED TO TROUBLESHOOT WITH THE CALLER. CALLER STATED HE TESTED CONTROLS WITH THE METER, AND THEY WERE IN RANGE. CALLER STATED THE RANGES ARE WAY TOO BROAD AND DON'T REFLECT THAT A METER IS AS ACCURATE AS IT SHOULD BE. REP THEN GATHERED CALLER'S FACILITY NAME, ADDRESS, AND PHONE NUMBER. THE ORIGINAL CALL WAS REGARDING A PATIENT WHO HAD OVERHEATED, WAS WEAK AND DIZZY AND WAS A BORDERLINE DIABETIC. THE MEDICS CHECKED AND RECEIVED THE READING OF 244. THE PATIENT HADN'T EATEN OR TAKEN ANY MEDICATION. THE TIME BET

  Patient problems: Insufficient Information

  MAUDE report 15119579 ↗
• MalfunctionJul 4, 2022Low Readings; Low Readings

  METER IS READING LO WITH BLOOD AND CS. BATTERIES WERE CHANGED. METER WAS BROUGHT ON A CALL. THE REASON FOR THE CALL WAS NOT A DIABETIC RELATED ISSUE. PATIENT WAS NOT EXHIBITING ANY DIABETIC SYMPTOMS. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST ON THE PATIENT BECAUSE THAT IS A STANDARD THING THEY DO ON ALL CALLS. PATIENT WAS NOT UNDERGOING OXYGEN THERAPY. PATIENT'S FINGER WAS CLEANSED USING AN ALCOHOL SWAB. PATIENT'S FINGERTIP WAS LANCED FOR BLOOD SAMPLE. THERE WAS NO TROUBLE GETTING A BLOOD SAMPLE DURING THE CALL. CALLER DESCRIBED THEIR TESTING PROCEDURE WHICH IS THE CORRECT WAY TO APPLY BLOOD TO THE TEST STRIP. PATIENT WAS NOT HAVING ANY BLOOD GLUCOSE RELATED SYMPTOMS. BLOOD GLUCOSE WAS TESTED, AND THE METER READ LO. USER WAS UNSURE IF THAT WAS CORRECT, AND THEY ALWAYS HAVE TWO METERS ON HAND, SO THEY USED THEIR OTHER METER TO CHECK BLOOD GLUCOSE AND RECEIVED A NORMAL READING. NO TREATMENT WAS PROVIDED BASED ON THE LO READING, AND NO TREATMENT WAS PROVIDED BASED ON ANY READING THEY RECEIVED DURING THAT CALL. CUSTOMER STATED THEY ALSO PERFORMED SEVERAL CS TESTS ON THE METER, AND IT IS ONLY READING LO. METER AND TEST STRIPS ARE STORED TOGETHER IN A CLIMATE-CONTROLLED ENVIRONMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14903269 ↗
• InjuryJun 28, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  CALLER REPORTED IN THE PAST WEEK OR SO, THEY HAVE HAD ISSUES WITH FOUR DIFFERENT DEVICES. THEY TALKED TO A SALES REPRESENTATIVE, AND SHE ADVISED TO REPORT THESE THROUGH CUSTOMER SERVICE. CALLER HAS ALL FOUR METERS AND ONE BOTTLE OF TEST STRIPS. CALLER DID NOT GRAB THE STRIPS THAT WERE WITH EACH METER. CALLER STATED HE DOES NOT HAVE CONTROL SOLUTION. CALLER REPORTED ON (B)(6), THEY TESTED THE PATIENT AT THE SCENE, AND IT READ "NORMAL", BUT CALLER DOESN'T KNOW WHAT THE EXACT READING WAS, AT IT IS NOT IN FRONT OF HIM. THE PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL AND RECEIVED "A SIGNIFICANT AMOUNT CARE" BEFORE THEY REALIZED THE PATIENT'S BLOOD SUGAR WAS 20. THAT WAS ONE OF THE FIRST "EVENTS" THAT THE CALLER WAS MADE AWARE THAT THE METERS WERE NOT WORKING CORRECTLY, BUT THEN IN THE NEXT FEW DAYS THE CALLER WAS MADE AWARE OF MORE "CASES" AND SAID THERE IS A DISPARITY BETWEEN WHAT THEY ARE SEEING IN THE FIELD AND WHAT THE HOSPITAL IS RECEIVING WHEN THE PATIENT IS BROUGHT THERE. CALLER BELIEVES THE METERS WERE PURCHASED IN 2018 BUT HAS NOT BEEN ABLE TO CONFIRM THAT WITH THIS VENDOR THAT HE PURCHASED THEM THROUGH. CALLER STATED HE FOUND OUT FROM THE SALES REP THAT THE METERS HAVE A THRE

  Patient problems: Hypoglycemia

  MAUDE report 14844734 ↗
• InjuryJun 28, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  CALLER REPORTED IN THE PAST WEEK OR SO, THEY HAVE HAD ISSUES WITH FOUR DIFFERENT DEVICES. THEY TALKED TO A SALES REPRESENTATIVE, AND SHE ADVISED TO REPORT THESE THROUGH CUSTOMER SERVICE. CALLER HAS ALL FOUR METERS AND ONE BOTTLE OF TEST STRIPS. CALLER DID NOT GRAB THE STRIPS THAT WERE WITH EACH METER. CALLER STATED HE DOES NOT HAVE CONTROL SOLUTION. CALLER REPORTED ON MARCH 28TH, THEY TESTED THE PATIENT AT THE SCENE, AND IT READ "NORMAL", BUT CALLER DOESN'T KNOW WHAT THE EXACT READING WAS, AT IT IS NOT IN FRONT OF HIM. THE PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL AND RECEIVED "A SIGNIFICANT AMOUNT CARE" BEFORE THEY REALIZED THE PATIENT'S BLOOD SUGAR WAS 20. THAT WAS ONE OF THE FIRST "EVENTS" THAT THE CALLER WAS MADE AWARE THAT THE METERS WERE NOT WORKING CORRECTLY, BUT THEN IN THE NEXT FEW DAYS THE CALLER WAS MADE AWARE OF MORE "CASES" AND SAID THERE IS A DISPARITY BETWEEN WHAT THEY ARE SEEING IN THE FIELD AND WHAT THE HOSPITAL IS RECEIVING WHEN THE PATIENT IS BROUGHT THERE. CALLER BELIEVES THE METERS WERE PURCHASED IN 2018 BUT HAS NOT BEEN ABLE TO CONFIRM THAT WITH THIS VENDOR THAT HE PURCHASED THEM THROUGH. CALLER STATED HE FOUND OUT FROM THE SALES REP THAT THE METERS HAVE A

  Patient problems: Hypoglycemia

  MAUDE report 14844658 ↗
• InjuryJun 28, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  CALLER REPORTED IN THE PAST WEEK OR SO, THEY HAVE HAD ISSUES WITH FOUR DIFFERENT DEVICES. THEY TALKED TO A SALES REPRESENTATIVE, AND SHE ADVISED TO REPORT THESE THROUGH CUSTOMER SERVICE. CALLER HAS ALL FOUR METERS AND ONE BOTTLE OF TEST STRIPS. CALLER DID NOT GRAB THE STRIPS THAT WERE WITH EACH METER. CALLER STATED HE DOES NOT HAVE CONTROL SOLUTION. CALLER REPORTED ON (B)(6), THEY TESTED THE PATIENT AT THE SCENE, AND IT READ "NORMAL", BUT CALLER DOESN'T KNOW WHAT THE EXACT READING WAS, AT IT IS NOT IN FRONT OF HIM. THE PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL AND RECEIVED "A SIGNIFICANT AMOUNT CARE" BEFORE THEY REALIZED THE PATIENT'S BLOOD SUGAR WAS 20. THAT WAS ONE OF THE FIRST "EVENTS" THAT THE CALLER WAS MADE AWARE THAT THE METERS WERE NOT WORKING CORRECTLY, BUT THEN IN THE NEXT FEW DAYS THE CALLER WAS MADE AWARE OF MORE "CASES" AND SAID THERE IS A DISPARITY BETWEEN WHAT THEY ARE SEEING IN THE FIELD AND WHAT THE HOSPITAL IS RECEIVING WHEN THE PATIENT IS BROUGHT THERE. CALLER BELIEVES THE METERS WERE PURCHASED IN 2018 BUT HAS NOT BEEN ABLE TO CONFIRM THAT WITH THIS VENDOR THAT HE PURCHASED THEM THROUGH. CALLER STATED HE FOUND OUT FROM THE SALES REP THAT THE METERS HAVE A THRE

  Patient problems: Hypoglycemia

  MAUDE report 14844652 ↗
• InjuryJun 28, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  CALLER REPORTED IN THE PAST WEEK OR SO, THEY HAVE HAD ISSUES WITH FOUR DIFFERENT DEVICES. THEY TALKED TO A SALES REPRESENTATIVE, AND SHE ADVISED TO REPORT THESE THROUGH CUSTOMER SERVICE. CALLER HAS ALL FOUR METERS AND ONE BOTTLE OF TEST STRIPS. CALLER DID NOT GRAB THE STRIPS THAT WERE WITH EACH METER. CALLER STATED HE DOES NOT HAVE CONTROL SOLUTION. CALLER REPORTED ON (B)(6), THEY TESTED THE PATIENT AT THE SCENE, AND IT READ "NORMAL", BUT CALLER DOESN'T KNOW WHAT THE EXACT READING WAS, AT IT IS NOT IN FRONT OF HIM. THE PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL AND RECEIVED "A SIGNIFICANT AMOUNT CARE" BEFORE THEY REALIZED THE PATIENT'S BLOOD SUGAR WAS 20. THAT WAS ONE OF THE FIRST "EVENTS" THAT THE CALLER WAS MADE AWARE THAT THE METERS WERE NOT WORKING CORRECTLY, BUT THEN IN THE NEXT FEW DAYS THE CALLER WAS MADE AWARE OF MORE "CASES" AND SAID THERE IS A DISPARITY BETWEEN WHAT THEY ARE SEEING IN THE FIELD AND WHAT THE HOSPITAL IS RECEIVING WHEN THE PATIENT IS BROUGHT THERE. CALLER BELIEVES THE METERS WERE PURCHASED IN 2018 BUT HAS NOT BEEN ABLE TO CONFIRM THAT WITH THIS VENDOR THAT HE PURCHASED THEM THROUGH. CALLER STATED HE FOUND OUT FROM THE SALES REP THAT THE METERS HAVE A THRE

  Patient problems: Hypoglycemia

  MAUDE report 14844637 ↗
• InjuryJun 28, 2022Low Readings; Low Readings

  CALLER STATED ONE OF THE METERS KEEPS READING LO. THEY STATED THEY CALIBRATED THE METER, AND IT KEEPS READING LO. REP. GATHERED CUSTOMER'S MAILING INFORMATION. CALLER STATED THEY HAD A PROBLEM WITH A PATIENT TODAY WHERE IT KEPT READING LO. SHE STATED THEY TOOK IT OUT OF SERVICE, THEY CHANGED THE BATTERIES, EVEN THOUGH NOTHING INDICATED THE BATTERIES WERE LOW, AND THEY TRIED TO PERFORM ANOTHER READING AND IT KEEPS READING LO. REP VERIFIED WHEN THEY WERE RECEIVING LO, AND CALLER STATED SHE PUTS A STRIP IN, DOES A READING, THE METER COUNTS DOWN AND READS LO. REP. GATHERED SERIAL NUMBER (B)(4). REP. THEN QUESTIONED IF THE CALLER HAD CONTROL SOLUTION, AND THE CALLER STATED SHE DID, AND THE REP ASKED IF THEY COULD PERFORM A CONTROL SOLUTION TEST. CALLER THEN PERFORMED A CONTROL TEST AND RECEIVED 37, NOT LO, AND RANGE IS 106-160. CALLER THEN ASKED WHAT IS THE LOWEST THE GLUCOMETER READS, AND REP CONFIRMED LO MEANS 20 OR LOWER. REP. THEN ASKED WHEN THE CONTROL SOLUTION WAS OPENED, AND CALLER CONFIRMED WITH ANOTHER PERSON IN THE ROOM THAT THE SOLUTION WAS OPENED TWO WEEKS AGO. REP. THEN ASKED THE CALLER IF THEY HAD ANOTHER BOTTLE OF UNOPENED CONTROL SOLUTION AND THE CALLER STATED THEY DO NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844386 ↗
• InjuryJun 28, 2022High Readings; High Readings

  CALLER STATED THEY HAVE BEEN HAVING REPEATED ISSUES WITH RECEIVING FALSELY LOW AND FALSELY HIGH NUMBERS FROM THE METERS. CALLER STATED THEY HAD A COUPLE SITUATIONS WHERE FOR EXAMPLE THE ASSURE PRISM WOULD READ 300, BUT THE HOSPITAL READINGS WOULD BE 600, 700, OR 900. CALLER ALSO GAVE AN EXAMPLE WHERE THE ASSURE PRISM METER WOULD READ 120, BUT THE HOSPITAL READING WAS 37. CALLER STATED THEY HAVE PULLED THE ASSURE PRISM METERS FROM SERVICE. CALLER STATED THEY HAVE PERFORMED MULTIPLE CONTROL SOLUTION TESTS AND THEY ARE ALL IN RANGE. REP THEN GATHERED CALLER'S FACILITY NAME, ADDRESS, PHONE NUMBER. REP QUESTIONED CALLER ABOUT DETAILS OF TIME WHEN READING WAS TAKEN, AND CALLER WASN'T EXACTLY SURE OF THE DETAILS AT THE TIME OF THE READING. CALLER THEN INFORMED REP THAT A METER HAD READINGS OF 120 AND 128 THAT WERE FIVE MINUTES APART. THIS WAS A KNOWN DIABETIC PATIENT THEY WERE FAMILIAR WITH WHO WAS HAVING A DIABETIC ISSUE. IT WAS NOTED DURING THE CALL THAT THE PATIENT HADN'T TAKEN ANY MEDICATIONS. READINGS WERE RECEIVED AROUND 11:51 AND THE PATIENT ARRIVED AT THE HOSPITAL AT 12:11 AND THE HOSPITAL RECEIVED A READING OF 37. CALLER WAS UNSURE IF THE HOSPITAL READING WAS VENOUS OR CAPILLARY.

  Patient problems: Hypoglycemia

  MAUDE report 14841005 ↗
• InjuryJun 28, 2022High Readings; High Readings

  CALLER STATED THEY HAVE BEEN HAVING REPEATED ISSUES WITH RECEIVING FALSELY LOW AND FALSELY HIGH NUMBERS FROM THE METERS. CALLER STATED THEY HAD A COUPLE SITUATIONS WHERE FOR EXAMPLE THE ASSURE PRISM WOULD READ 300, BUT THE HOSPITAL READINGS WOULD BE 600, 700, OR 900. CALLER ALSO GAVE AN EXAMPLE WHERE THE ASSURE PRISM METER WOULD READ 120, BUT THE HOSPITAL READING WAS 37. CALLER STATED THEY HAVE PULLED THE ASSURE PRISM METERS FROM SERVICE. CALLER STATED THEY HAVE PERFORMED MULTIPLE CONTROL SOLUTION TESTS AND THEY ARE ALL IN RANGE. REP THEN GATHERED CALLER'S FACILITY NAME, ADDRESS, PHONE NUMBER. REP QUESTIONED CALLER ABOUT DETAILS OF TIME WHEN READING WAS TAKEN, AND CALLER WASN'T EXACTLY SURE OF THE DETAILS AT THE TIME OF THE READING. CALLER THEN INFORMED REP THAT A METER HAD READINGS OF 120 AND 128 THAT WERE FIVE MINUTES APART. THIS WAS A KNOWN DIABETIC PATIENT THEY WERE FAMILIAR WITH WHO WAS HAVING A DIABETIC ISSUE. IT WAS NOTED DURING THE CALL THAT THE PATIENT HADN'T TAKEN ANY MEDICATIONS. READINGS WERE RECEIVED AROUND 11:51 AND THE PATIENT ARRIVED AT THE HOSPITAL AT 12:11 AND THE HOSPITAL RECEIVED A READING OF 37. CALLER WAS UNSURE IF THE HOSPITAL READING WAS VENOUS OR CAPILLARY.

  Patient problems: Hypoglycemia

  MAUDE report 14840954 ↗
• InjuryJun 28, 2022High Readings; High Readings

  ON PATIENT, CUSTOMER RECEIVED READING OF 244 WHICH SEEMED HIGH TO CUSTOMER, SO THEY HAD "RESCUE" (AFTER FURTHER LISTENING THIS IS PRESUMED TO BE THE FIRE DEPARTMENT) CHECK THE PATIENT WITH THEIR MONITOR, AND IT READ 180. "RESCUE" ENDED UP TAKING THE PATIENT TO THE HOSPITAL. AT THE HOSPITAL THE READING WAS 178. THIS ALL OCCURRED WITH 20 MINUTES, SO CALLER STATED THE PATIENT COULDN'T HAVE BURNED THAT MUCH SUGAR. CALLER IS CONCERNED THAT THEY WILL UNDERTREAT OR OVERTREAT IF THE READINGS ON THE METERS AREN'T CORRECT. CALLER STATED THEY JUST STARTED USING THE ASSURE PRISM METER SYSTEM. REP THEN CHECKED VARIANCE OF NUMBERS. VARIANCE IS 26-27% AND READINGS ARE ALL IN ZONE A. REP THEN OFFERED TO TROUBLESHOOT WITH THE CALLER. CALLER STATED HE TESTED CONTROLS WITH THE METER, AND THEY WERE IN RANGE. CALLER STATED THE RANGES ARE WAY TOO BROAD AND DON'T REFLECT THAT A METER IS AS ACCURATE AS IT SHOULD BE. REP THEN GATHERED CALLER'S FACILITY NAME, ADDRESS, AND PHONE NUMBER. THE ORIGINAL CALL WAS REGARDING A PATIENT WHO HAD OVERHEATED, WAS WEAK AND DIZZY AND WAS A BORDERLINE DIABETIC. THE MEDICS CHECKED AND RECEIVED THE READING OF 244. THE PATIENT HADN'T EATEN OR TAKEN ANY MEDICATION. THE TIME BE

  Patient problems: Hyperglycemia

  MAUDE report 14840898 ↗
• MalfunctionMar 23, 2022Low Readings; Low Readings

  CUSTOMER REPORTED ISSUES OF SOLUTION OUT OF RANGE. COMPLAINT WAS REVIEWED FOR INVESTIGATION AND REPORTABILITY ON (B)(6) 2022. COMPLAINT WAS MARKED FOR INVESTIGATION AND DETERMINED NOT REPORTABLE PER ARKRAY'S PER INTERNAL PROCEDURES. ON (B)(6) 2022, RETURNED STRIPS FAILED TESTING BY GENERATING LOW RESULTS OUT OF SPECIFICATION. THE STRIPS GAVE LOW READINGS, MAKING THIS COMPLAINT REPORTABLE TO THE MANUFACTURER AS A MALFUNCTION. (B)(6) 2022 MARKS THE AWARE DATE FOR MDR FILING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866812 ↗
• InjuryJan 22, 2020High Test Results; High Test Results

  ON (B)(6) 2019 AT 0618, MED 1 WAS DISPATCHED FOR A POSSIBLE DIABETIC EMERGENCY. UPON ARRIVAL WE FOUND A (B)(6) FEMALE PATIENT ON BED IN RESIDENCE. THE PATIENT HAD STROKE LIKE SYMPTOMS. PATIENTS FAMILY STATED THEY HAD NOT SPOKEN TO THE PATIENT SINCE ABOUT 1900 HOURS LAST NIGHT. WE CHECKED BLOOD SUGAR AND IT SHOWED 63MG/DL. OUR UNIT TRANSPORTED THE PATIENT UNDER A STROKE ALERT. THE ER RECEIVED A BLOOD SUGAR READING OF 24MG/DL. IT IS UNKNOWN EXACTLY WHAT KIND OF TREATMENT THE PATIENT HAD AT THE HOSPITAL. USES THE SECOND DROP OF BLOOD. STORES IN THE CARRYING CASE, INSIDE THE CONTROL TEMPERATURE IN A MEDICINE CABINET AREA IN THE BACK OF THE AMBULANCE, WHERE IS IT TEMPERATURE CONTROLLED AT 70-75 DEGREES. VERIFIED THEY CHANGE THE LANCETS, CLEAN FINGER WITH ALCOHOL AND USES THE FINGERTIP AS A TESTING SITE. VERIFIED THE PATIENT DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD AND IS NOT UNDERGOING OXYGEN THERAPY. IT IS UNKNOWN IF THERE'S BEEN ANY CHANGES TO THE PATIENT'S DIET, MEDICATION OR STRESS LEVELS. VERIFIED THE STRIPS HAVE BEEN OPENED LESS THAN ONE MONTH. THE SUPPLIES HAVEN'T BEEN EXPOSED TO ANY EXTREME TEMPERATURES. THEY PERFORM CONTROL SOLUTION TEST DAILY BUT DID NOT PERFORM A CS DUR

  Patient problems: Hypoglycemia

  MAUDE report 9619450 ↗