MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-07-15 for REFLOTRON GPT 10745138203 manufactured by Roche Diagnostics.
[18968896]
Manufacturing error occurred during the production of the suspect test strips. An alpha-ketoglutarate coating is either partially or entirely missing on the transparency foil which leads to falsely low gpt results for patient controls.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2004-00575 |
| MDR Report Key | 592428 |
| Report Source | 07 |
| Date Received | 2004-07-15 |
| Date of Report | 2004-06-24 |
| Date Mfgr Received | 2004-06-24 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2005-04-20 |
| 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 | DEBARA REESE |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON GPT |
| Generic Name | CLINICAL CHEMISTRY REAGENT |
| Product Code | CKD |
| Date Received | 2004-07-15 |
| Model Number | NA |
| Catalog Number | 10745138203 |
| Lot Number | 23717132 |
| ID Number | NA |
| Device Expiration Date | 2004-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 582276 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | SANDHOFER STRASSE 116 MANNHEIM GM D-68298 |
| Baseline Brand Name | REFLOTRON GPT |
| Baseline Generic Name | GPT |
| Baseline Model No | NA |
| Baseline Catalog No | 10745138203 |
| Baseline ID | 745138 |
| Baseline Device Family | CLINICAL CHEMISTRY REAGENT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K864082 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-15 |