ASSURE® PRISM MULTI BLOOD GLUCOSE METER 530001Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00015482530013), received between Jan 27, 2017 and Aug 26, 2024 — classified as 14 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Low Readings” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024High Readings; High Readings

  CALLER STATED THEY RECEIVED THE METER TWO MONTHS AGO. CALLER STATED THE METER AND STRIPS ARE STORED ON THE AMBULANCE. CALLER STATED THEY WERE CALLED FOR AN UNRESPONSIVE PATIENT. THEY TESTED THE METER TWICE WITH THE PATIENT AND RECEIVED BLOOD GLUCOSE READINGS OF 219 ((B)(6) 2024 AT 8:09 PM) AND 212 (B)(6) 2024 AT 8:08 PM). THE PATIENT WAS NOT TREATED BY THE AMBULANCE PERSONNEL BASED ON THE READINGS THEY RECEIVED. THE AMBULANCE CREW ACTIVATED STROKE PROTOCOL. THEY TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM AND THE EMERGENCY ROOM TESTED THE PATIENT'S BLOOD GLUCOSE WITH THEIR METER AND REGISTERED THEIR BLOOD GLUCOSE AT 54. THE CALLER STATED THIS METER IS READING TOO HIGH BASED ON THE READINGS RECEIVED WITH THIS METER AND THE READING THAT WAS RECEIVED AT THE EMERGENCY ROOM. THE EMERGENCY ROOM FURTHER TREATED THE PATIENT WITH ACTIVATED STROKE PROTOCOL AND MEDICATIONS, BUT THEIR COMPLETE COURSE OF TREATMENT IS UNKNOWN. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND SENT RETURN LABEL.

  Patient problems: Altered State of Consciousness; Hypoglycemia

  MAUDE report 20061887 ↗
• InjuryAug 12, 2024High Readings; High Readings

  CALLER STATED THEY RECEIVED THE METER TWO MONTHS AGO. CALLER STATED THE METER AND STRIPS ARE STORED ON THE AMBULANCE. CALLER STATED THEY WERE CALLED FOR AN UNRESPONSIVE PATIENT. THEY TESTED THE METER TWICE WITH THE PATIENT AND RECEIVED BLOOD GLUCOSE READINGS OF 219 ( (B)(6) 2024 AT 8:09 PM) AND 212 ( (B)(6) 2024 AT 8:08 PM). THE PATIENT WAS NOT TREATED BY THE AMBULANCE PERSONNEL BASED ON THE READINGS THEY RECEIVED. THE AMBULANCE CREW ACTIVATED STROKE PROTOCOL. THEY TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM AND THE EMERGENCY ROOM TESTED THE PATIENT'S BLOOD GLUCOSE WITH THEIR METER AND REGISTERED THEIR BLOOD GLUCOSE AT 54. THE CALLER STATED THIS METER IS READING TOO HIGH BASED ON THE READINGS RECEIVED WITH THIS METER AND THE READING THAT WAS RECEIVED AT THE EMERGENCY ROOM. THE EMERGENCY ROOM FURTHER TREATED THE PATIENT WITH ACTIVATED STROKE PROTOCOL AND MEDICATIONS, BUT THEIR COMPLETE COURSE OF TREATMENT IS UNKNOWN. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND SENT RETURN LABEL.

  Patient problems: Altered State of Consciousness; Hypoglycemia

  MAUDE report 19968215 ↗
• InjuryApr 12, 2024Low Readings; Low Readings

  CALLER IS REPORTING THAT THEY HAVE HAD TWO INCIDENTS WITH THIS METER, THE FIRST ONE ON 3/13/2024 AND THE SECOND ONE ON 3/17/2024, WHERE THE METER WAS READING LOWER THAN BLOOD READINGS AT THE HOSPITAL. METER AND STRIPS ARE ALWAYS STORED ON THE RIG IN NORMAL CONDITIONS. FOR THE FIRST INCIDENT ON 3/13/2024, CALLER REPORTED THAT THE EMS READING WITH THIS METER WAS 396 AT 9:26 AM ON 3/13/2024, THE HOSPITAL CAPILLARY READING WAS SOMEWHERE IN THE 500'S, AND THE LAB TEST RESULT WAS ABOUT 621. FOR THE SECOND INCIDENT ON 3/17/2024, THE REPORTER DID NOT HAVE SPECIFIC DETAILS ON THE READINGS THAT WERE RECEIVED, ONLY THAT THEY WERE LOWER. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND SENT RETURN LABEL. THIS REPORT IS IN REFERENCE TO THE SECOND INCIDENT ON 3/17/2024.

  Patient problems: Insufficient Information

  MAUDE report 19101483 ↗
• InjuryApr 12, 2024Low Readings; Low Readings

  CALLER IS REPORTING THAT THEY HAVE HAD TWO INCIDENTS WITH THIS METER, THE FIRST ONE ON (B)(6) 2024 AND THE SECOND ONE ON (B)(6) 2024, WHERE THE METER WAS READING LOWER THAN BLOOD READINGS AT THE HOSPITAL. METER AND STRIPS ARE ALWAYS STORED ON THE RIG IN NORMAL CONDITIONS. FOR THE FIRST INCIDENT ON (B)(6) 2024, CALLER REPORTED THAT THE EMS READING WITH THIS METER WAS 396 AT 9:26 AM ON (B)(6) 2024, THE HOSPITAL CAPILLARY READING WAS SOMEWHERE IN THE 500'S, AND THE LAB TEST RESULT WAS ABOUT 621. FOR THE SECOND INCIDENT ON (B)(6) 2024, THE REPORTER DID NOT HAVE SPECIFIC DETAILS ON THE READINGS THAT WERE RECEIVED, ONLY THAT THEY WERE LOWER. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND SENT RETURN LABEL. THIS REPORT IS IN REFERENCE TO THE FIRST INCIDENT ON (B)(6) 2024.

  Patient problems: Hyperglycemia

  MAUDE report 19101028 ↗
• InjuryMar 19, 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 18931638 ↗
• InjuryJun 5, 2023Low Readings; Low Readings

  THE CUSTOMER STATED METER K008006K1319 GAVE A READING OF 450, BUT WHEN THEY GOT TO THE HOSPITAL THE READING WAS 1,300. CUSTOMER WAS UNABLE TO PROVIDE STRIP LOT INFORMATION AS THEY NO LONGER HAD THE STRIPS THAT WERE USED DURING THE INCIDENT. CUSTOMER ALSO REPORTED THAT THEY PERFORMED A CONTROL SOLUTION TEST WHEN THEY RETURNED AND THE CONTROL SOLUTION TEST DID PASS TESTING WITHIN RANGE, BUT THEY WERE NOT ABLE TO PROVIDE THE CONTROL SOLUTION LOT NUMBER. DURING THE SECOND CALL ON (B)(6) 2023, THE CALLER INDICATED THAT METER K008006K1319 HAD THE VALUE OF 297 AND UPON METER RETURN, THAT VALUE WAS FOUND IN THE RECENT METER MEMORY. ON (B)(6) 2023 AND (B)(6) 2023 PRODUCT COMPLAINT ANALYST ATTEMPTED TO CONTACT THE CALLER FOR FOLLOW-UP TO GATHER AND CONFIRM MORE INFORMATION ABOUT THESE METERS, BUT WAS UNABLE SPEAK WITH THE CUSTOMER, BUT DID LEAVE A VOICEMAIL REQUESTING THE CALLER TO GIVE US A CALL BACK TO PROVIDE MORE INFORMATION. PRODUCT COMPLAINT ANALYST DID FINALLY SPEAK TO THE CALLER TODAY ((B)(6) 2023). CUSTOMER CONFIRMED THAT THE READING OF 297 WAS ON METER K008006K1319, AND THE VALUE OF 450 WAS RECEIVED ON METER K008119H2326. THE REASON SHE SAID SHE DIDN'T SEND K008119H2326 BACK IS BEC

  Patient problems: Hyperglycemia

  MAUDE report 17057785 ↗
• InjuryMay 18, 2023Low Readings; Low Readings

  EMS WENT TO A CALL, AND THEY RECEIVED A READING OF 297, BUT WHEN THEY TRANSPORTED THE PATIENT TO THE HOSPITAL, THE READING RECEIVED WAS 1,940. REPORTER DOES NOT KNOW HOW MUCH TIME PASSED BETWEEN THE READING THEY RECEIVED AND THE READING THE HOSPITAL RECEIVED. THE REPORTER DID NOT KNOW IF TREATMENT WAS ALTERED DUE TO THE READING AND SHE WAS NOT SURE, BUT STATED PROBABLY NOT, AS THEY NORMALLY WOULD HAVE JUST TRANSPORTED THE PATIENT TO THE HOSPITAL. THEY DID A CONTROL TEST AFTER RETURNING TO THE STATION AND THE METER READ WITHIN RANGE ON THE CS TEST. THE REPORTER DOES NOT HAVE THE TEST STRIPS OR CONTROL SOLUTION ANYMORE, SO THE LOT INFORMATION IS NOT AVAILABLE FOR EITHER THE TEST STRIPS OR THE CONTROL SOLUTION. REPLACED METER AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia

  MAUDE report 16959392 ↗
• InjuryMay 5, 2023Low Readings; Low Readings

  THIS CALL WAS ORIGINALLY RECEIVED ON (B)(6) 2023, AND THE CALLER REFERENCED TWO METERS. HOWEVER, THE REPRESENTATIVE WHO TOOK THE CALL ONLY LOGGED ONE METER (K008006K1319) AND NOT THE METER REFERENCED WITHIN THIS CALL. AUDIO REVIEW OF THE ORIGINAL CALL WAS DONE ON (B)(6) 2023, WHERE IT WAS DISCOVERED THAT THE CUSTOMER CALLED ABOUT TWO METERS. THE REPRESENTATIVE WHO TOOK THE CALL WILL RECEIVE ADDITIONAL TRAINING TO ENSURE THEY LOG ALL METERS THAT ARE REFERENCED WITHIN A COMPLAINT. ORIGINALLY THEY CUSTOMER SAID THIS METER GAVE A READING OF 297, BUT WHEN THEY GOT TO THE HOSPITAL THE READING WAS 1,940. THE CUSTOMER STATED METER K008006K1319 GAVE A READING OF 450, BUT WHEN THEY GOT TO THE HOSPITAL THE READING WAS 1,300. CUSTOMER WAS UNABLE TO PROVIDE STRIP LOT INFORMATION AS THEY NO LONGER HAD THE STRIPS THAT WERE USED DURING THE INCIDENT. CUSTOMER ALSO REPORTED THAT THEY PERFORMED A CONTROL SOLUTION TEST WHEN THEY RETURNED AND THE CONTROL SOLUTION TEST DID PASS TESTING WITHIN RANGE, BUT THEY WERE NOT ABLE TO PROVIDE THE CONTROL SOLUTION LOT NUMBER. DURING THE SECOND CALL ON (B)(6) 2023, THE CALLER INDICATED THAT METER K008006K1319 HAD THE VALUE OF 297 AND UPON METER RETURN, THAT VALUE W

  Patient problems: Hyperglycemia

  MAUDE report 16879665 ↗
• InjuryMay 5, 2023Low Readings; Low Readings

  CUSTOMER ORIGINALLY CALLED ON (B)(6) 2023, HOWEVER, THEY NEEDED TO GATHER MORE INFORMATION, AND THE MAJORITY OF THE INFORMATION RECEIVED WAS ON(B)(6) 2023, SO THE COMPLAINT WAS LOGGED THAT DAY, BUT THE AWARE DATE OF THE ISSUE WAS (B)(6) 2023. EMS WENT TO A CALL, AND THEY RECEIVED A READING OF 297, BUT WHEN THEY TRANSPORTED THE PATIENT TO THE HOSPITAL, THE READING RECEIVED WAS 1,940. REPORTER DOES NOT KNOW HOW MUCH TIME PASSED BETWEEN THE READING THEY RECEIVED AND THE READING THE HOSPITAL RECEIVED. THE REPORTER DID NOT KNOW IF TREATMENT WAS ALTERED DUE TO THE READING AND SHE WAS NOT SURE, BUT STATED PROBABLY NOT, AS THEY NORMALLY WOULD HAVE JUST TRANSPORTED THE PATIENT TO THE HOSPITAL. THEY DID A CONTROL TEST AFTER RETURNING TO THE STATION AND THE METER READ WITHIN RANGE ON THE CS TEST. THE REPORTER DOES NOT HAVE THE TEST STRIPS OR CONTROL SOLUTION ANYMORE, SO THE LOT INFORMATION IS NOT AVAILABLE FOR EITHER THE TEST STRIPS OR THE CONTROL SOLUTION. REPLACED METER AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia

  MAUDE report 16879142 ↗
• InjuryJul 28, 2022Non Reproducible Results; Non Reproducible Results

  REP CALLED CUSTOMER AFTER RECEIVING AN EMAIL FROM SALES REP ABOUT ISSUE. ASKED CUSTOMER IF SHE HAS ALL THREE METERS THAT HAD ISSUES. CUSTOMER DOES NOT HAVE THE METERS. CUSTOMER THREW ONE AWAY THINKING IT WAS JUST A ONE-OFF ISSUE. REP WENT OVER SOME VARIABLES THAT CAN CAUSE THE FLUCTUATIONS IN READINGS. REP ASKED CUSTOMER HOW MANY METERS SHE HAS, AND CUSTOMER STATED SHE HAS ONE SHE CAN GET A SERIAL NUMBER FROM, AND SHE WOULD HAVE TO CALL THE STATION TO GET THE OTHER INFORMATION. FIRST ISSUE WAS LAST THURSDAY OR FRIDAY WITH THE METER SHE HAS. THERE WAS ABOUT A 200-POINT DIFFERENCE. EMS WAS DISPATCHED FOR A DIABETIC EMERGENCY. PATIENT WASN'T FEELING WELL. FIRE WAS ON THE SCENE FIRST, ASSESSED THE PATIENT, TOOK BLOOD SUGAR AND READING WAS 110. WHEN THE AMBULANCE GOT THERE, THE PATIENT'S BLOOD SUGAR WAS 300. READINGS WERE WITHIN 10 MINUTES. NO MEDICATIONS WERE ADMINISTERED TO THE PATIENT, ALL THEY DID WAS PUT A SALINE LINE IN AND DID 8-10 CCS TO FLUSH IT. VERIFIED IT WAS A FINGERSTICK TEST AND THEY DISINFECTED FINGER BEFORE TAKING THE READING. REP ASKED ABOUT STORAGE AND COMBINING STRIPS AND CALLER INDICATED THEY STORE IN THE SAME BOTTLE THEY COME IN. CUSTOMER ENDED CALL TO TAKE ANOTHER

  Patient problems: Insufficient Information

  MAUDE report 15119584 ↗
• InjuryJun 28, 2022Low Readings; Low Readings

  REP CALLED CUSTOMER AFTER RECEIVING AN EMAIL FROM SALES REP ABOUT ISSUE. ASKED CUSTOMER IF SHE HAS ALL THREE METERS THAT HAD ISSUES. CUSTOMER DOES NOT HAVE THE METERS. CUSTOMER THREW ONE AWAY THINKING IT WAS JUST A ONE-OFF ISSUE. REP WENT OVER SOME VARIABLES THAT CAN CAUSE THE FLUCTUATIONS IN READINGS. REP ASKED CUSTOMER HOW MANY METERS SHE HAS, AND CUSTOMER STATED SHE HAS ONE SHE CAN GET A SERIAL NUMBER FROM, AND SHE WOULD HAVE TO CALL THE STATION TO GET THE OTHER INFORMATION. FIRST ISSUE WAS LAST THURSDAY OR FRIDAY WITH THE METER SHE HAS. THERE WAS ABOUT A 200-POINT DIFFERENCE. EMS WAS DISPATCHED FOR A DIABETIC EMERGENCY. PATIENT WASN'T FEELING WELL. FIRE WAS ON THE SCENE FIRST, ASSESSED THE PATIENT, TOOK BLOOD SUGAR AND READING WAS 110. WHEN THE AMBULANCE GOT THERE, THE PATIENT'S BLOOD SUGAR WAS 300. READINGS WERE WITHIN 10 MINUTES. NO MEDICATIONS WERE ADMINISTERED TO THE PATIENT, ALL THEY DID WAS PUT A SALINE LINE IN AND DID 8-10 CCS TO FLUSH IT. VERIFIED IT WAS A FINGERSTICK TEST AND THEY DISINFECTED FINGER BEFORE TAKING THE READING. REP ASKED ABOUT STORAGE AND COMBINING STRIPS AND CALLER INDICATED THEY STORE IN THE SAME BOTTLE THEY COME IN. CUSTOMER ENDED CALL TO TAKE ANOTHER

  Patient problems: Insufficient Information

  MAUDE report 14841049 ↗
• MalfunctionMar 8, 2022Low Readings; Low Readings

  CUSTOMER REPORTED ISSUES OF DOES NOT REGISTER SOLUTION/BLOOD. COMPLAINT WAS REVIEWED FOR INVESTIGATION AND REPORTABILITY ON 11/15/2021. COMPLAINT WAS MARKED FOR INVESTIGATION AND DETERMINED NOT REPORTABLE PER ARKRAY'S PER INTERNAL PROCEDURES. ON DECEMBER 16, 2021 RETURNED METER, FAILED TESTING BY GENERATING LOW RESULTS, OUT OF SPECIFICATION. THE METER GAVE LOW READINGS, MAKING THIS COMPLAINT REPORTABLE TO THE MANUFACTURER AS A MALFUNCTION. DECEMBER 16, 2021, MARKS THE AWARE DATE FOR MDR FILING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691917 ↗
• MalfunctionApr 23, 2021Low Readings; Low Readings

  CALLER RECEIVED A READING OF 96MG/DL (WHICH WAS OUT OF RANGE) ON THIS ONE USING SAME STRIPS AND CONTROL SOLUTION. CUSTOMER WAS UNCOOPERATIVE WITH TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715030 ↗
• InjurySep 11, 2019High Test Results; High Test Results

  WE RECEIVED AN EMAIL REPORT FROM BOUND TREE FROM THIS FACILITY STATING, "GLUCOMETER MALFUNCTIONING, READING TOO HIGH, MAY NEED TO BE CALIBRATED." ATTEMPTED TO CONTACT CUSTOMER BUT HE WILL NOT BE IN UNTIL NEXT THURSDAY. I SPOKE WITH THE FIRE CHIEF BUT SHE WASN'T AWARE OF THE SITUATION AT ALL, SO SHE TOOK DOWN THE INFORMATION AND SAID THAT SHE WILL HAVE HIM CONTACT ME. CUSTOMER DID CALL BACK AND ABOUT A WEEK AGO, THEY HAD A CALL WHERE THERE WAS A DIABETIC EMERGENCY AND OUR METER READ SOMEWHERE IN THE 200'S BUT HE DOESN'T KNOW FOR SURE BECAUSE HE WASN'T THERE. THEN THEY USED A DIFFERENT BRAND METER AND RECEIVED A READING IN THE 50'S AND A THIRD METER AND THAT ONE WAS IN THE 40-50 RANGE ALSO. THEY TESTED THIS METER WITH SOMEONE AT THE STATION WITH THIS METER AND RECEIVED THE SAME RESULTS. CALLER DOESN'T KNOW ABOUT HOW TESTS WERE PERFORMED, CLEANING OR SPECIFICS AS FAR AS WHAT WAS DONE. THEY HAVE NEVER PERFORMED CONTROL TESTS ON ANY OF THEIR METERS, SO I AM SENDING SOME. HE JUST SAID THE PERSON WAS TAKEN TO THE HOSPITAL. REPLACED METER SYSTEM AND SENT RETURN LABEL FOR CUSTOMER TO RETURN PRODUCT.

  Patient problems: Hypoglycemia

  MAUDE report 8989330 ↗
• InjurySep 11, 2019High Test Results; High Test Results

  THE PROVIDERS ASSESSED A PATIENT'S BLOOD GLUCOSE VIA CAPILLARY BLOOD AND THE METER READ 290. AFTER ARRIVING AT THE EMERGENCY DEPARTMENT, IT WAS DETERMINED THAT THE PATIENT'S BLOOD GLUCOSE WAS 17. THE PROVIDER TOOK THE GLUCOMETER OUT OF SERVICE AND PERFORMED SEVERAL ASSESSMENTS INCLUDING ASSESSING HER PERSONAL BLOOD GLUCOSE AS WELL AS USING BOTH TEST SOLUTIONS. ALL RETURNED A NORMAL READING. THEY CONTACTED RANDY CAMPBELL WITH BOUND TREE WHO ADVISED THEM TO CONTACT THE 800 NUMBER FOR REPORTING. THEY CONTACTED CUSTOMER SERVICE (CUSTOMER ELATION) WHO WALKED THEM THROUGH USING THE TEST SOLUTION TO DO A TEST WHICH READ WITHIN THE NORMAL LIMITS OF THE SOLUTION. SHE ADVISED ME THERE WAS NO REASON TO RETURN THE DEVICE AS NO FURTHER TESTING WOULD OCCUR GIVEN THE METER READ NORMAL USING THE SOLUTION. THE CALLER DOES NOT KNOW HOW OLD THE METER IS. UNABLE TO GATHER STRIP LOT INFORMATION. REPLACED METER, STRIPS AND SENT RL.

  Patient problems: Hypoglycemia

  MAUDE report 8988838 ↗
• MalfunctionApr 24, 2018Low Test Results; Low Test Results

  CALLER SAID THAT METER IS READING LOW WITH THE LEVEL 2 CONTROL SOLUTION. TRIED TO DO A CONTROL SOLUTION TEST, BUT IT WOULD NOT GIVE A READING. ITEMS ARE KEPT TOGETHER IN POUCH. THE POUCHES ARE STORED ON THE TRUCK IN A NEUTRAL TEMPERATURE AREA. REPLACED METER, STRIPS, CS, AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453636 ↗
• InjuryApr 13, 2018Low Test Results; Low Test Results

  THE NURSE STATED THAT THE PATIENT WASN'T FEELING GOOD AT ALL YESTERDAY. THEY DID NOT THINK IT WAS RELATED TO HIS BLOOD SUGAR BECAUSE HIS TESTS WERE COMING BACK NORMAL. YESTERDAY AROUND DINNER TIME THE NURSE TESTED ON THE PATIENT AND RECEIVED A READING OF 106. SHE STATED OVER A PERIOD OF ONE HOUR HE WAS ACTING CONFUSED AND THEY CALLED THE PARAMEDICS TO SEND THE PATIENT TO THE HOSPITAL. AFTER ARRIVING TO THE HOSPITAL, THEY TOOK HIS BLOOD GLUCOSE READING AND RECEIVED HI. THE NURSE IS UNSURE IF THE PATIENT HAD ANY FOOD, MEDICATION, OR BEVERAGES TWO HOURS PRIOR. SHE IS ALSO UNSURE IF THE PATIENT WAS TREATED WITH ANY MEDICATION BUT STATED THAT HE IS STILL IN THE HOSPITAL IN ICU. THE PATIENT IS NOT RECEIVING ANY OXYGEN THERAPY. THE PATIENT DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD. THE FACILITY IS USING ONE-TIME USE LANCETS TO GET A BLOOD SAMPLE. THEY USE ALCOHOL TO CLEAN THE PATIENT'S FINGER. THEY ALLOW THE FINGERTIP TO DRY THOROUGHLY. I VERIFIED THAT THE TEST STRIP BOTTLE IS SEALED TIGHTLY AND IMMEDIATELY AFTER REMOVING A STRIP. THE TEST STRIPS ARE STORED IN A ROOM THAT'S COOL AND DRY WITH STEADY TEMPERATURES. THERE HAVE NOT BEEN ANY CHANGES IN THE PATIENT'S DIET, EXERCISE, MEDICAT

  Patient problems: Hyperglycemia

  MAUDE report 7428232 ↗
• MalfunctionFeb 28, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CALLER IS REPORTING BLOOD VARIABLE RESULTS. CALLER EXPLAINS THAT HE WENT ON AN EMERGENCY CALL "AROUND THE WEEK OF (B)(6) ". STATES THAT PATIENT WAS NEARLY UNCONSCIOUS FROM AN ISSUE THAT IS NOT RELATED TO OUR METER SYSTEM. HE CLEANED PATIENTS FINGER WITH ALCOHOL AND ALLOWED TO DRY. PERFORMED A FINGER STICK TO OBTAIN BLOOD SAMPLES. HE TESTED WITH THE PRISM METER AND GOT A READING OF 90. HE DID NOT FEEL THAT WAS CORRECT AND DID ANOTHER TEST IMMEDIATELY AND GOT A RESULT OF 390. HE TRIED AGAIN AND GOT AN ERROR BUT DOES NOT KNOW WHICH ERROR IT WAS. HE LACKED CONFIDENCE IN THE METER RESULTS AND GOT ANOTHER BRAND OF METER FROM THE AMBULANCE AND TESTED AND GOT A READING OF 30 WHICH WAS CONSISTENT WITH THE PATIENT'S SYMPTOMS. THEY TREATED THE PATIENT BASED ON THE 30 TEST RESULT. STATES THAT HE DID A CONTROL TEST ON THIS METER AND THE TEST FOR HIGH AND LOW WERE WITHIN RANGE ON THE TEST STRIP BOTTLE, HOWEVER HE PERFORMED TWO CONTROL TESTS BACK TO BACK WITH THE SOLUTION AND GOT 195-218. BOTH RESULTS WERE IN RANGE. HE WANTS TO KNOW WHY THERE IS NOT AN EXACT NUMBER. I EXPLAINED THAT THERE CAN BE SLIGHT VARIANCES FROM STRIPS TO STRIP BUT THE SYSTEM IS CONSIDERED TO BE WORKING WHEN THE RESULTS ARE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6364802 ↗
• MalfunctionJan 27, 2017High Readings; High Readings

  CALLER IS REPORTING HIGH BLOOD READINGS. CALLER STATES THAT A CO-WORKER WAS UNRESPONSIVE AND THEY DID A BLOOD TEST AND RECEIVED A 214. DOESN'T KNOW IF THE FINGER WAS CLEANED FOR SURE BUT ASSUMES IT WAS AN ALCOHOL WIPE. THE TEMPERATURE WAS 71 DEGREES. THEY TOOK HIM TO THE HOSPITAL FIVE MINUTES LATER AND THEY RECEIVED A READING OF 31 BUT SHE DOESN'T KNOW IF IT WAS BLOOD DRAW OR FINGER STICK. THE PATIENT DID NOT TAKE INSULIN BEFORE OCCURRENCE. SHE DOESN'T KNOW WHAT MEDS THAT THE PATIENT MAY BE ON. METER IS STORED IN TRUCK IN THE BACK AND KEPT WARM. SHE IS COMPLAINING THAT THEY HAVE HAD OTHER ISSUES WITH THESE METERS AND DOESN'T TRUST THE ASSURE PRISM. I DID EXPLAIN THAT THEY ARE USED IN LONG TERM CARE FACILITIES THAT DO NOT HAVE AN ISSUE. SHE WANTS TO SWITCH TO A DIFFERENT METER. CALLER WAS GETTING UPSET AND UNCOOPERATIVE. THE VARIANCE IS 85.5% AND FALLS WITHIN THE C RANGE OF THE PARKES GRID. CONTROLS WERE USED AND RESULTS WERE IN RANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6283413 ↗