droplet pen needlesRecalls & reported problems across all models
Htl Strefa S A · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 9 models of droplet pen needles by Htl Strefa S A in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2018 and Jun 1, 2026 — classified as 3 injuries, 98 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (40 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported droplet pen needles problems
Device problems
- Material Twisted/Bent40
- Dull, Blunt25
- Infusion or Flow Problem18
- No Flow9
- Material Fragmentation8
- Obstruction of Flow6
- Appropriate Device Problem Term/Code Not Available5
- Break5
Patient problems
- No Information62
- No Clinical Signs, Symptoms or Conditions15
- Hyperglycemia6
- No Code Available5
- Foreign Body In Patient4
- Needle Stick/Puncture3
- No Known Impact Or Consequence To Patient3
- Bruise/Contusion2
droplet pen needles models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- droplet® pen needles 31G x 8mmNeedle, Hypodermic, Single Lumen54 reports
- droplet® pen needles 31G x 5mmNeedle, Hypodermic, Single Lumen24 reports
- droplet® pen needles 32Gx4mmNeedle, Hypodermic, Single Lumen8 reports
- droplet® pen needles 31Gx8mmNeedle, Hypodermic, Single Lumen5 reports
- droplet® pen needles 32G x 5mmNeedle, Hypodermic, Single Lumen4 reports
- droplet® pen needles 32G x 6mmNeedle, Hypodermic, Single Lumen2 reports
- droplet®, pen needles 31G x 8 mmNeedle, Hypodermic, Single Lumen2 reports
- droplet® pen needles 32Gx6mmNeedle, Hypodermic, Single Lumen1 report
- droplet® pen needles 29G x 12mmNeedle, Hypodermic, Single Lumen1 report
Recent droplet pen needles adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 1, 2026Break; Fluid/Blood Leak; Material Fragmentation; Material Twisted/Bent
ON 05/22/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLE HAVE BENT AND BROKEN OFF IN THE SKIN DURING INJECTIONS. HE WAS ABLE TO REMOVE THE BROKEN NEEDLES USING TWEEZERS. HE ALSO MENTIONED INSULIN SPILLING OUT OF THE PEN NEEDLE DURING INJECTION ATTEMPT RESULTING IN A SPIKE OF HIS SUGAR LEVELS. THE CUSTOMER REPORTED A SUGAR SPIKE OF MORE THAN 300. THE CUSTOMER DID SEEK MEDICAL ATTENTION FOR THE SPIKE OR BROKEN NEEDLES. HE USES LANTUS SOLOSTAR. THE CUSTOMER CONFIRMED ROTATING INJECTION SITES AND FOLLOWS THE IFU. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. ADDITIONAL INFORMATION: THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION AND WAS ABLE TO REMOVE THE BROKEN NEEDLE USING TWEEZERS. YES, HIS SUGAR LEVELS ARE NORMAL NOW AND HE IS IN GOOD CONDITION. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED TO HTL-STREFA S.A. FOR FURTHER ANALYSIS.
Patient problems: Foreign Body In Patient; Hyperglycemia
MAUDE report 25346162 ↗MalfunctionMay 15, 2026No Flow
ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES FAILED TO PRIME AND DISPENSE INSULIN. SHE SAID DROP OF INSULIN WAS NOT VISIBLE AT THE END OF THE PEN NEEDLE TIP. SHE CONFIRMED FOLLOWING THE IFU AND DID NOT SUFFER ANY HEALTH CONSEQUENCE FROM THE COMPLAINT. SHE USES TOUJEO AND NOVALOG INSULIN PENS AND CONFIRMED HAVING THE ISSUE WITH BOTH PENS. SHE SAID OVER 12 PEN NEEDLES HAVE FAILED OVER TWO BOXES. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183959 ↗MalfunctionApr 3, 2026No Flow
ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES HAVE FAILED TO DISPENSE INSULIN. SHE HAS 10 FAILURES OUT OF HER CURRENT BOX. SHE USES LANTUS SOLOSTAR INJECTION PEN. SHE CONFIRMED THAT SHE FOLLOWS THE IFU AND DID NOT SUFFER ANY MIS DOSING OR HEALTH CONSEQUENCE. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781234 ↗InjuryApr 3, 2026No Flow
ON 03/16/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HER PEN NEEDLES ARE FAILING TO DISPENSE FULL DOSE OF INSULIN. CUSTOMER SAID MOST OF THE PEN NEEDLES SHE HAS USED FROM HER CURRENT BOX HAVE FAILED TO DISPENS. CUSTOMER CONFIRMED THROUGH GLUCOSE FREESTYLE MONITORING SYSTEM THAT HER SUGAR HAD SPIKE TO 200 PLUS. SHE WAS ABLE TO REDUCE HER LEVELS WITH ANOTHER INJECTION. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT SUFFER ANY MAJOR HEALTH CONSEQUENCE. SHE USES HUMALOG AND LANTUS SOLOSTAR PEN INJECTORS. CUSTOMER CONFIRMED PRIMING PEN NEEDLES PRIOR TO INJECTION AND FOLLOWS THE IFU. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.
Patient problems: Hyperglycemia
MAUDE report 24773757 ↗MalfunctionMar 26, 2026No Flow
ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES FAILED TO PRIME AND DISPENSE INSULIN. CUSTOMER USES THE LANTUS SOLOSTAR PEN INJECTOR. CUSTOMER DID NOT SUFFER ANY MIS DOSING FROM THE COMPLAINT. THE CUSTOMER STATED IT TAKES DIALING UNITS 2 TO 3 TIMES AND THEN THE INSULIN SHOOTS OUT OF THE PEN NEEDLE AS IF IT'S UNDER PRESSURE. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. ON 2026-03-23 SAMPLE UNDER COMPLAINT HAS BEEN RETURNED FOR FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696137 ↗MalfunctionMar 16, 2026No Flow
ON 02/26/2026 HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT. THE COMPLAINT HAS BEEN REGISTERED IN HTL-STREFA S. A COMPLIANT HANDLING SYSTEM ON 03/02/2026. CUSTOMER STATED: I AM WRITING TO EXPRESS CONCERN REGARDING THE QUALITY OF THE 0.23X4MM DROPLET PEN NEEDLES. I HAVE HAD 2 BOXES OF 100 NEEDLES FROM WHICH APPROXIMATELY 1 OUT OF 4 NEEDLES DOES NOT WORK. I DIDN'T SAVE THE LOT NUMBER FROM THE FIRST BOX BECAUSE I DIDN'T THINK I'D RUN INTO THE PROBLEM AGAIN BUT UNFORTUNATELY, I AM HAVING THE SAME PROBLEM WITH A SECOND BOX. THE LOT NUMBER IS F58A4. I AM ATTACHING A PICTURE OF THE LABEL ON THE END OF THE BOX THAT CONTAINS ALL THE IDENTIFYING INFORMATION. BOTH OF THESE BOXES WERE PURCHASED AT A WALGREENS DRUG STORE ON 12/15/2025. I USE EACH OF THESE NEEDLES ONLY ONCE FOR 4 INJECTIONS PER DAY. I USE A HUMALOG KWIKPEN 3 TIMES DAILY AND A LANTUS SOLOSTAR PEN 1 TIME DAILY. TO HAVE THE NEEDLES FAIL AS OFTEN AS THESE ARE FAILING IS FRUSTRATING AND COSTLY. I HAVE READ AND REREAD THE INSTRUCTIONS AND WHILE I HAVE HAD NEEDLES FAIL PREVIOUSLY, THEY HAVE NOT FAILED AS FREQUENTLY AS THEY ARE NOW. I BELIEVE THE PART OF THE NEEDLE THAT PIERCES THE MEMBRANE AT THE END OF THE INSULIN PENS BENDS SO NO INSUL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603397 ↗MalfunctionMar 16, 2026No Flow
ON 03/02/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HER PEN NEEDLES ARE FAILING TO DISPENSE THE INSULIN DURING HER INJECTION. SHE HAS 20 CONFIRMED FAILED PEN NEEDLES OUT OF HER LAST 3 BOXES. CUSTOMER CONFIRMED THE PEN NEEDLE DID NOT BEND ON USER OR NON-USER END WHILE ATTACHING PEN NEEDLE TO INJECTOR PEN. SHE USES TRESIBA AND NOVALOG INJECTOR PENS. CUSTOMER CONFIRMED THAT SHE FOLLOWS THE IFU AND ROTATES INJECTION SITES. SHE DID NOT SUFFER ANY MIS DOSING OR SERIOUS INJURY FROM THE COMPLAINT. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603265 ↗MalfunctionMar 16, 2026No Flow
ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES FAILED TO DISPENSE INSULIN. HE SAID THE INSULIN FAILED TO PRIME. HE ALSO SAID THE PEN NEEDLES ARE DIFFICULT TO REMOVE FROM THE PEN INJECTOR, STATING THE PROTECTIVE CAP FAILS TO REMOVE THE PEN NEEDLE FOLLOWING INJECTION. HE STATED 6 PEN NEEDLES HAVE FAILED OF THE 20 PEN NEEDLES USED OUT THE BOX OF 100. CUSTOMER CONFIRMED FOLLOWING THE IFU AND USES LANTUS SOLOSTAR PEN INJECTOR. HE DID NOT SUFFER MIS DOSING OR HEALTH CONSEQUENCE FROM THE COMPLAINT. WE ARE PROVIDING REPLACEMENT SAMPLES AND CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. ON 2026-03-04 PRODUCT INVOLVED IN THE EVENT HAS BEEN RETURNED TO HTL-STREFA S.A. FOR FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603040 ↗MalfunctionFeb 10, 2026No Flow
BETWEEN (B)(6) 2026, HTL-STREFA S.A. RECEIVED 10 COMPLAINTS FROM THE U.S. MARKET. ALL OF THE COMPLAINTS CONCERN THE F58A4 LOT, AND ALL INVOLVE USERS REPORTING PROBLEMS WITH CLOGGED NEEDLES AND PEN NEEDLES THAT FAIL TO DISPENSE INSULIN. THE FULL DESCRIPTION OF THE COMPLAINTS IS BELOW: "ON (B)(6) 2026 HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT. CUSTOMER STATED: I WAS TOLD BY A WALGREENS PHARMACY EMPLOYEE TO CONTACT THE MANUFACTURER ABOUT THE DEFECTIVE PEN NEEDLES I'VE ENCOUNTERED IN THE BOX THAT I PURCHASED AROUND CHRISTMAS TIME IN 2025. I MUST HAVE FOUND AT LEAST A DOZEN BAD NEEDLES SO FAR, THE DEFECT BEING THAT AS I CONTINUE TO DIAL IN THE INSULIN AT 2 UNITS AT A TIME, NOTHING COMES OUT. ANOTHER NEEDLE FIXES THE PROBLEM BUT I'M WASTING SEVERAL NEEDLES IN THE PROCESS." "ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER SAID SEVERAL PEN NEEDLES HAVE FAILED TO DISPENSE INSULIN. CUSTOMER CONFIRMED FOLLOWING THE IFU AND DID NOT SUFFER ANY MIS DOSING OR HEALTH CONSEQUENCE FROM COMPLAINT. HE USES HUMALOG PEN INJECTOR.". "ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HIS PEN NEEDLES ARE FAILING TO DISPENSE INSULIN. HE SAYS 1 OUT 3 P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302191 ↗InjuryJan 30, 2026Material Twisted/Bent
ON 01/07/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER'S PEN NEEDLES ARE BENDING ON CONTACT WITH THE SKIN. HE REPORTED 2 PEN NEEDLES HAD 90-DEGREE ANGLE BENDS WHEN HE REMOVED THE PEN NEEDLE FOLLOWING INJECTION ATTEMPT. HE DID HAVE MIS DOSING FOLLOWING ONE INJECTION WHERE HIS LEVEL RECORDED A 315. HE WAS ABLE TO BALANCE HIS LEVELS AFTER EATING SOMETIME LATER. CUSTOMER DID NOT SUFFER ANY ADDITIONAL INJURIES OR HEALTH CONSEQUENCES. CUSTOMER USES FLEXPEN FOR HIS INJECTIONS. CUSTOMER CONFIRMED FOLLOWING THE IFU AND ROTATING INJECTION SITES. WE ARE SENDING REPLACEMENT SAMPLES AND CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE FORM THE CUSTOMER HAS NOT BEEN RETURNED FOR FURTHER ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 24220933 ↗MalfunctionJan 8, 2026Material Twisted/Bent
(B)(6) 2025, HTL-STREFA RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED EXPERIENCE SEVERAL PEN NEEDLES HAVE BENT ON CONTACT. CUSTOMER INJECTS 3 TIMES PER DAY. CUSTOMER HAS REPORTED MIS DOSING WITH OF HIS INJECTIONS DISCOVERED THROUGH A MONITORING DEVICE. HE WAS ABLE TO ACHIEVE HIS REQUIRED DOSE USING A DIFFERENT PEN NEEDLE AND DID NOT SEEK MEDICAL ATTENTION. CUSTOMER CONFIRMED HE FOLLOWS THE IFU AND ROTATES INJECTION SITES. CUSTOMER IS CONCERNED THE PEN NEEDLES ARE NOT MEETING SPECIFICATION AND WOULD LIKE THE MANUFACTURER TO INVESTIGATION. HE USES SOLIQUA PEN INJECTOR. WE ARE PROVIDING REPLACEMENT SAMPLES, AND WE ARE NOT CERTAIN IF THE CUSTOMER WILL HAVE AVAILABLE SAMPLES FOR INVESTIGATION ANALYSIS.ADDITIONAL QUESTION ABOUT BLOOD SUGAR LEVEL HAS BEEN SENT TO THE PATIENT. DESPITE MULTIPLE ATTEMPTS, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED DUE TO THE LACK OF CONTACT WITH THE USER.ON 2026-01-16 SAMPLE UNDER COMPLAINT HAS BEEN RETURNED FOR FURTHER ANALYSIS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24003242 ↗MalfunctionDec 16, 2025Break; Material Fragmentation; Dull, Blunt; Break; Material Fragmentation; Dull, Blunt
ON 12/10/2025 (B)(6). RECEIVED A PHONE CALL COMPLAINT PEN NEEDLES ARE FAILING TO PENETRATE THE SKIN. THE PEN NEEDLES WILL NOT PENETRATE THE SKIN WITHOUT EXCESSIVE FORCE. HE DESCRIBED THE PEN NEEDLES AS DULL. A PEN NEEDLE BROKE OFF INTO HIS SKIN, FORTUNATELY ENOUGH OF THE PEN NEEDLE WAS STICKING OUT AND HE WAS ABLE TO REMOVE IT WITH HIS FINGERS. HE DOES NOT FEEL COMFORTABLE USING THE PEN NEEDLES HE HAS CURRENTLY. HE USES LANTUS SOLOSTAR FOR HIS PEN INJECTIONS. HE HAS USED DROPLET PEN NEEDLES FOR 2 OR 3 YEARS AND CONFIRMED HE FOLLOWS THE IFU AND ROTATES INJECTION SITES. HE SUFFERED MIS DOSING BUT WAS ABLE TO ACHIEVE HIS REQUIRED DOSE USING A MONITORING DEVICE. HE DID NOT SUFFER ANY OTHER HEALTH CONSEQUENCE AND DID NOT SEEK ANY MEDICAL ATTENTION. WE ARE PROVIDING REPLACEMENT SAMPLES, AND WE EXPECT TO RECEIVE REPLACEMENT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS BEEN NOT RETURNED OF FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816091 ↗MalfunctionDec 16, 2025Break; Material Fragmentation; Material Twisted/Bent; Break; Material Fragmentation; Material Twisted/Bent
ON 12/10/2025 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HIS PEN NEEDLES ARE BENDING ON CONTACT WITH THE SKIN. HE ALSO SAID A PEN NEEDLE BROKE OFF INTO HIS SKIN AND HE HAD TO REMOVE IT USING TWEEZERS. HE USES HUMALOG, LANTUS, AND OZEMPIC PEN INJECTORS. HE ALSO REPORTED HAVING 5 TO 8 PEN NEEDLE THAT DID NOT HAVE A NEEDLE PRESENT. HE DID NOT SUFFER ANY MIS DOSING OR HEALTH CONSEQUENCES, ONLY THE NEEDLE THAT BROKE OFF THAT HE REMOVED. CUSTOMER CONFIRMED HE FOLLOWS THE IFU AND ROTATES INJECTION SITES. WE ARE PROVIDING REPLACEMENT PRODUCT, AND HE WAS NOT ABLE TO CONFIRM IF SAMPLES FOR INVESTIGATION ANALYSIS WOULD BE AVAILABLE. SAMPLE UNDER COMPLAINT HAS BEEN NOT RETURNED OF FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815280 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent
ON (B)(6) 2025 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES BENDS ON CONTACT WITH THE SKIN DURING INJECTION ATTEMPTS. CUSTOMER STATED SHE RECENTLY SWITCHED TO DROPLET FROM ANONTHER BRAND. SHE STATED SUFFERING A SPIKE IN HER SUGAR LEVELS AFTER PEN NEEDLE BENT DURING HER INJECTION ATTEMPT. SHE CONFIRMED SEEING SOME OF THE INSULIN ON THE SKIN FOLLOWING THE ATTEMPT. SHE DID NOT SUFFER ANY OTHER HEALTH CONSEQUENCE AND DID NOT REQUIRE HOSPITAL VISIT OR OTHER HEALTH CARE SERVICES. SHE USES BASAGLAR FOR HER INJECTIONS. SHE CONFIRMED FOLLOWING THE IFU AND ROTATES INJECTIONS SITES. WE ARE PROVIDING REPLACEMENT SAMPLES, AND SHE AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. HTL-STREFA S.A. MADE AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION TO THE EVENT CIRCUMSTANCES - WITHOUT RESULTS. NO SAMPLE WAS RETURNED TO HTL-STREFA FOR FURTHER EVALUATION.
Patient problems: Insufficient Information
MAUDE report 23298148 ↗MalfunctionJun 30, 2023Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent
PATIENT CALLED ON (B)(6) 2023 AT 11:59 AM. PATIENT RECEIVED 3 BOXES OF DROPLET PEN NEEDLES 32G X 6MM FROM BAKER'S PHARMACY WITH LOT C56H8. PATIENT HAS USED DROPLET PEN NEEDLES IN THE PAST, AND HE HAS NOT HAD ANY ISSUES. PATIENT CLAIMS THAT ABOUT 25%-50% OF THE PEN NEEDLES ARE BENDING. PATIENT CLAIMS THAT HE NOTICES THE BENDING BOTH AS HE IS TRYING TO INJECT HIS INSULIN AND WHEN HE IS REMOVING THE PEN NEEDLE FROM THE SKIN. PATIENT HAS USED ABOUT 28 NEEDLES OF THE LOT NUMBER SO FAR. PATIENT CLAIMS THAT SOME INSULIN WILL LEAK OUT OF THE SKIN, AND THAT SOME INSULIN WILL STICK TO THE INSULIN PEN NEEDLE WHEN REMOVING IT. PATIENT IS UNSURE IF HE IS RECEIVING HIS FULL DOSAGE OF INSULIN, AND HE CLAIMS THAT HIS BLOOD SUGAR HAS BEEN HIGHER THAN USUAL. PATIENT HAS NOT SOUGHT NOR RECEIVED MEDICAL ATTENTION FOR THE ISSUE, AND AS OF NOW, HE DOES NOT PLAN TO. PATIENT INJECTS 8-10 UNITS OF INSULIN 3 TIMES PER DAY USING THE NOVALOG FLEXPEN, AND HE INJECTS 56 UNITS OF INSULIN ONCE PER DAY USING THE TOUJEO SOLOSTAR PEN. PATIENT CLAIMS THAT HE IS ROTATING INJECTION SITES, AND THAT THE NEEDLES ARE BENDING AT EACH INJECTION SITE THAT HE SELECTS. WE ARE REPLACING THE NEEDLES, AND WE ARE EXPECTING SAMPLES.
Patient problems: Hyperglycemia
MAUDE report 17243677 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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