MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2001-05-22 for DISETRONIC TENDER UNK manufactured by Maersk Medical A/s.
[22186371]
In 2001 the end-user had changed the infusion set. Next morning enduser woke up and end user's blood sugar level was 32. 0. End user had boulssed some extra insulin (16 units). After this end user's blood sugar level was 34. 0. End user bolussed some more insulin and end user's blood sugar level became 37. 0. End user contacted end user's hospital by phone. They gave end user the advise to take end user's spare pump (what end user did). End user bolussed some extra insulin with end user's insulin pen (in end user's arm) by 7:00 pm enduser's blood sugar level was 10. 3. On april 9, 2001 maersk medical received the complaint and 1 used infusion set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021545-2001-00023 |
| MDR Report Key | 334549 |
| Report Source | 06,08 |
| Date Received | 2001-05-22 |
| Date of Report | 2001-05-03 |
| Date of Event | 2001-01-30 |
| Date Mfgr Received | 2001-04-09 |
| Date Added to Maude | 2001-05-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. EFRAIN CARRERO |
| Manufacturer Street | 6001 SOUTH 35TH STREET SUITE B |
| Manufacturer City | MCALLEN TX 78503 |
| Manufacturer Country | US |
| Manufacturer Postal | 78503 |
| Manufacturer Phone | 1956683847 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISETRONIC TENDER |
| Generic Name | SUBCUTANEOUS INFUSION SET |
| Product Code | FDZ |
| Date Received | 2001-05-22 |
| Returned To Mfg | 2001-04-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 323893 |
| Manufacturer | MAERSK MEDICAL A/S |
| Manufacturer Address | AAHOLMVEJ 1-3, OSTED ROSKILDE DA DK-4000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-05-22 |