MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-17 for COBAS INTEGRA 800 28122474692 manufactured by Roche Diagnostics.
[3971040]
The customer received questionable hemoglobin a1c results for approximately 150 patient samples and qc material. A physician called and questioned the results. Samples were either repeated on the same analyzer or another integra 800 at the site. Data was only provided for one patient sample as an example. The initial result was 7. 3% and the repeat results on (b)(6) 2013 were 5. 4 % and 5. 3%. All of the erroneous results were reported outside the laboratory. The repeat results were believed to be correct. There were no adverse events. The hemoglobin a1c reagent lot number and expiration date were not provided. The tech operating the analyzer at time of the event stated he was able to correct the issue, but specific information was not provided. The field service representative noted it was likely the analyzer experienced a full or partial probe clot during the run and was in need of replacement. The post run qc results were not validated to expose the errors and subsequently maintenance was performed and may have corrected the issue without knowledge of samples in need of corrective actions. He communicated to the customer the order of events and suggested additional instrument health checks, such as probe throughput checks, to ensure accurate results. He successfully verified the analyzer was in working order with proper calibration and qc results.
Patient Sequence No: 1, Text Type: D, B5
[11322937]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-07700 |
| MDR Report Key | 3522968 |
| Report Source | 05,06 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-12-17 |
| Date of Event | 2013-12-06 |
| Date Mfgr Received | 2013-12-10 |
| Date Added to Maude | 2013-12-17 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2013-12-17 |
| Model Number | NA |
| Catalog Number | 28122474692 |
| Lot Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-17 |