MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-03-17 for COBAS 8000 MODULAR ANALYZER SERIES 05964075001 manufactured by Roche Diagnostics.
[1920612]
The user experienced imprecision for the calcium assay and performed a precision check with patient samples. Of the data provided, the results for 10 patient samples were discrepant. All results are in mg/dl. The exact date of testing was not provided for the following samples. The repeat testing was performed on the integra 800 analyzer. The calcium reagent lot number used for these samples was 632822. Patient sample 1 initial result was 6. 2 and the repeat result was 9. 6. Patient sample 2 initial result was 7. 1 and the repeat result was 10. 0. Patient sample 3 initial result was 7. 4 and the repeat result was 10. 2. Patient sample 4 initial result was 7. 6 and the repeat result was 10. 1. Patient sample 5 initial result was 8. 0 and the repeat result was 10. 2. The following patient samples were tested on (b)(6) 2011. The repeat testing was performed on the cobas 8000. The calcium reagent lot number used for these samples was 638401. Patient sample 6 initial result was 5. 8 and the repeat result was 10. 0. Patient sample 7 initial result was 6. 0 and the repeat result was 10. 1. Patient sample 8 initial result was 7. 6 and the repeat result was 9. 9. Patient sample 9 initial result was 6. 2 and the repeat result was 9. 0. Patient sample 10 initial result was 6. 7 and the repeat result was 10. 1. No adverse events were alleged regarding the issue.
Patient Sequence No: 1, Text Type: D, B5
[8834891]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9244485]
The investigation determined this issue may be a customer specific problem. Although intensive maintenance actions were performed, the proven reagent carry-over from magnesium could not be eliminated. This phenomenon seemed to be related to this individual instrument and it was assumed that the washing accuracy was weak. To solve the intermittent issue, an extra wash between magnesium and calcium was introduced which solved the issue. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
[9287677]
Additional information was received for patient sample 1 affecting the following medwatch fields: (b)(6). Sex was male. (b)(4). Date of event was actual (b)(6) 2011 not (b)(6) 2011 as previously reported. Date received by manufacturer was (b)(4) 2011 not (b)(4) 2011 as previously reported. The erroneous calcium result was rejected by the lab expert and the test was repeated. The results of 9. 6 mg/dl was reported outside the laboratory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-01454 |
| MDR Report Key | 2022197 |
| Report Source | 01,05,06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-07-22 |
| Date of Event | 2011-02-21 |
| Date Mfgr Received | 2011-02-21 |
| Date Added to Maude | 2011-03-17 |
| 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 RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| Manufacturer G1 | HITACHI HIGH TECH. CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 MODULAR ANALYZER SERIES |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JFP |
| Date Received | 2011-03-17 |
| Model Number | NA |
| Catalog Number | 05964075001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-17 |