MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-08-29 for OMNIPOD INSULIN PUMP 15880 ZXR425 manufactured by Insulet Corporation.
[84105373]
The product was not returned for evaluation. We are unable to confirm the reported bent cannula or to determine whether it contributed to the reported hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria. Omnipod insulin management system? User guide. Model: cat45e/cat45f 15546-aw rev d 06/2016 checking your blood glucose 7 / page 98. Warning: if you get results below 3. 9 mmol/l or above 13. 9 mmol/l, but do not have symptoms of hypoglycemia or hyperglycemia repeat the test. If you have symptoms or continue to get results that fall below 3. 9 mmol/l or above 13. 9 mmol/l, follow the treatment advice of your healthcare provider.
Patient Sequence No: 1, Text Type: N, H10
[84105374]
It was reported that patient's blood glucose levels reached 14. 1 mmol/l (254 mg/dl) while wearing the pod between 24 and 36 hours on the leg. Correction boluses were attempted but were unsuccessful and the pod was removed. The customer noted the cannula was bent. A new pod was applied to treat the hyperglycemia.
Patient Sequence No: 1, Text Type: D, B5
[114356526]
The returned product was evaluated and performed as designed. Inspection of the cannula assembly did not find it bent, kinked, or damaged. No issues noted that would cause high blood glucose levels.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004464228-2017-04313 |
| MDR Report Key | 6826659 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-10-09 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2017-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEREK SAMMARCO |
| Manufacturer Street | 600 TECHNOLOGY PARK DRIVE SUITE 200 |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 9786007000 |
| Manufacturer G1 | INSULET CORPORATION |
| Manufacturer Street | 600 TECHNOLOGY PARK DRIVE SUITE 200 |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPOD INSULIN PUMP |
| Generic Name | PUMP, INFUSION, INSULIN |
| Product Code | LZG |
| Date Received | 2017-08-29 |
| Returned To Mfg | 2017-09-25 |
| Model Number | 15880 |
| Catalog Number | ZXR425 |
| Lot Number | L43124 |
| Device Expiration Date | 2018-11-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSULET CORPORATION |
| Manufacturer Address | 600 TECHNOLOGY PARK DRIVE SUITE 200 BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-29 |