MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-26 for COBAS INTEGRA 800 28122474692 manufactured by Roche Diagnostics.
[3649172]
The customer discovered questionable hemoglobin a1c results for 143 patient samples when a run of 150 patient samples was repeated on another integra 800 after the results for four patient samples were questioned. Data was only provided for five patient samples, of which the results for four were discrepant. Patient sample 1 initial result was 7. 9%, the repeat result was 6. 1%. Patient sample 2 initial result was 8. 6%, the repeat result was 7. 0%. Patient sample 3 initial result was 15. 4%, the repeat result was 12. 2%. Patient sample 4 initial result was 8. 0%, the repeat result was 6. 0%. The initial results were reported outside the laboratory. The repeat results were believed to be correct. Corrected reports were issued for 143 patient samples. No patients were adversely affected. The hemoglobin a1c reagent lot number was 66927201 with an expiration date of 01/31/2014. The field service representative could not find a cause. To verify the analyzer operation, he ran performance testing which passed.
Patient Sequence No: 1, Text Type: D, B5
[11064058]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[15948997]
The investigation could not determine a specific root cause. Based on the number of patient samples involved, an issue with pipetting or sedimentation of the samples was likely.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05148 |
| MDR Report Key | 3308399 |
| Report Source | 05,06 |
| Date Received | 2013-08-26 |
| Date of Report | 2013-12-03 |
| Date of Event | 2013-08-07 |
| Date Mfgr Received | 2013-08-09 |
| Date Added to Maude | 2013-08-26 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2013-08-26 |
| Model Number | NA |
| Catalog Number | 28122474692 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-08-26 |