MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-09 for COBAS C111 04777433001 manufactured by Roche Diagnostics.
[15008158]
The user stated that she had been using calcium reagent lot 616892-01 with no problems, but she ran out and put old lot 613188-01 onto the analyzer. She ran 12 patient plasma samples and the results "were off". She stated after replacing the reagent with lot 616892-01, she reran the patient samples and the results were acceptable. The user provided results for eleven patient samples, of which nine were discrepant. All results are in mg per dl. On (b) (6) 2009, sample 1 initial result was 13. 1, repeat result on the same lot was 11. 1. Sample 2 initial result was 10. 9, repeat result on the same lot was 9. 6. On (b) (6) 2009, sample 3 initial result was 11. 0, repeat result on the same lot was 9. 9. Sample 4 initial result was 11. 8, repeat result on the same lot was 10. 2. On (b) (6) 2009, sample 5 initial result was 11. 2, repeat result on the same lot was 9. 6. Sample 6 initial result was 10. 2, repeat result on the same lot was 11. 4, repeat result on lot 616892-01 was 9. 6. Sample 7 initial result was 10. 2, repeat result on the same lot was 9. 6, repeat result on lot 616892-01 was 9. 1. Sample 8 initial result was 10. 2, repeat result on the same lot was 10. 0, repeat result on lot 616892-01 was 9. 2. Sample 9 initial result was 10. 5, repeat result on the same lot was 9. 8, repeat result on lot 616892-01 was 9. 5. The user stated she reported the lowest result from the original and reruns for all 12 patient samples. No adverse reaction occurred form the reporting of these results.
Patient Sequence No: 1, Text Type: D, B5
[15522596]
If additional information is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2009-08295 |
| MDR Report Key | 1580993 |
| Report Source | 05,06 |
| Date Received | 2009-12-09 |
| Date of Report | 2009-12-09 |
| Date of Event | 2009-11-16 |
| Date Facility Aware | 2009-11-18 |
| Report Date | 2009-11-18 |
| Date Mfgr Received | 2009-11-18 |
| Date Added to Maude | 2010-03-02 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS C111 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | JFP |
| Date Received | 2009-12-09 |
| Model Number | C111 |
| Catalog Number | 04777433001 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-09 |