MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-22 for COBAS INTEGRA IGA GEN 2 03507343190 manufactured by Roche Diagnostics.
[75628939]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75628940]
The customer received questionable iga-2 tina-quant iga gen. 2 results for eight patient samples from a pack of reagent that had just a few tests remaining. The customer used cobas 8000 c 502 module serial number (b)(4). The customer removed the suspect pack and loaded a new reagent pack onto the analyzer. They repeated the samples on the original analyzer and/or a second cobas 8000 c 502 module. Of the data provided for seven of the patient samples, only the results for five patient samples were discrepant. Sample 1 initial result was 589 mg/dl and the repeat result was 278 mg/dl. Sample 2 initial result was 8 mg/dl with a data flag. The repeat result on the original analyzer was 2924 mg/dl and the repeat result on the second analyzer was 225 mg/dl. Sample 3 initial result was 464 mg/dl and the repeat result was 349 mg/dl. Sample 4 initial result was 1165 mg/dl and the repeat result was 283 mg/dl. Sample 5 initial result was 1474 mg/dl and the repeat result was 246 mg/dl. The initial results were reported outside the laboratory. As the repeat result matched between the two analyzers, they were believed to be correct. The repeat results were immediately called to the ordering physicians. There was no adverse event. The field service representative found there was an issue with the reagent pack as it was near the end of its usefulness. The reagent pack was replaced and system integrity checks, qc, and precision testing were performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01060 |
| MDR Report Key | 6581449 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-22 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-05-05 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-05-22 |
| 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 | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA IGA GEN 2 |
| Generic Name | IMMUNOGLOBULIN A |
| Product Code | CZP |
| Date Received | 2017-05-22 |
| Model Number | NA |
| Catalog Number | 03507343190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-22 |