MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-11-09 for PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAB manufactured by Medtronic Minimed.
[2365082]
The customer reported a battery out limit alarm after a battery change. The customer also reported being hospitalized due to diabetes complications. The customer reported a blood glucose reading of 294 mg/dl. Nothing further was reported.
Patient Sequence No: 1, Text Type: D, B5
[9487215]
Currently, it is unk whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We, therefore, consider this report complete to the best of our knowledge.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032227-2011-02826 |
| MDR Report Key | 2341705 |
| Report Source | 04 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-10-23 |
| Date of Event | 2011-10-23 |
| Date Mfgr Received | 2011-10-23 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2011-11-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTOPHER TUPPER, MANAGER |
| Manufacturer Street | 18000 DEVONSHIRE ST. |
| Manufacturer City | NORTHRIDGE CA 913251219 |
| Manufacturer Country | US |
| Manufacturer Postal | 913251219 |
| Manufacturer Phone | 8185764313 |
| Manufacturer G1 | MEDTRONIC MINIMED |
| Manufacturer Street | 18000 DEVONSHIRE ST. |
| Manufacturer City | NORTHRIDGE CA 91325 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91325 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARADIGM REAL-TIME INSULIN INFUSION PUMP |
| Generic Name | INSULIN INFUSION PUMP |
| Product Code | MBS |
| Date Received | 2011-11-09 |
| Model Number | MMT-722LNAB |
| Catalog Number | MMT-722LNAB |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MINIMED |
| Manufacturer Address | 18000 DEVONSHIRE ST. NORTHRIDGE CA 91325 US 91325 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-11-09 |