MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-07-07 for ACCU-CHEK COMPACT 3149072 manufactured by Roche Diagnostics.
[418018]
Customer reported device = 365 mg/dl. Customer was teken to the hosp and their device = 147 mg/dl. No treatment was received. Controls were used but not certain if values are within range. A request was made for return product and replacement product was sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2005-01887 |
| MDR Report Key | 620483 |
| Report Source | 04 |
| Date Received | 2005-07-07 |
| Date of Report | 2005-06-24 |
| Date of Event | 2005-06-24 |
| Date Mfgr Received | 2005-06-24 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-07-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOF LITTWITZ |
| Manufacturer Street | 9115 HAGUE RD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-CHEK COMPACT |
| Generic Name | BLOOD GLUCOSE MONITORING DEVICE |
| Product Code | NBN |
| Date Received | 2005-07-07 |
| Returned To Mfg | 2005-07-15 |
| Model Number | NA |
| Catalog Number | 3149072 |
| Lot Number | 20623744 |
| ID Number | NA |
| Device Expiration Date | 2005-10-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 610168 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | ACCU-CHECK COMPACT |
| Baseline Generic Name | BLOOD GLUCOSE MONITORING DEVICE |
| Baseline Model No | * |
| Baseline Catalog No | 3149072 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-07-07 |