MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-13 for COBAS 6000 CORE 05036453001 manufactured by Roche Diagnostics.
[1877571]
The customer received intermittent questionable results for multiple assays for approximately one week. The assays involved were alanine aminotransferase, aspartate aminotransferase, bicarbonate and calcium. The issue involved an unknown number of patients and occurred when the reagent packs were low (less than 30 tests). The customer provided results for eight patient samples. The alanine aminotransferase without pyridoxal phosphate activation (alt) results for one sample were discrepant. The initial alt result was 1 u/l and was reported outside the laboratory. The sample was repeated on an integra 400 and recovered 79 u/l. This result was sent outside the laboratory in a corrected report. The patient was not adversely affected by the event. The alt reagent lot number was 63220401. The field service representative determined a reagent sampling issue was the cause. He cleaned and lubricated the x drive assembly for the r2 probe. He reinstalled the r2 syringe barrel and performed all probe alignments. All diagnostics and customer's controls were acceptable.
Patient Sequence No: 1, Text Type: D, B5
[9172365]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02038 |
| MDR Report Key | 2054189 |
| Report Source | 05,06 |
| Date Received | 2011-04-13 |
| Date of Report | 2011-04-13 |
| Date of Event | 2011-03-29 |
| Date Mfgr Received | 2011-03-29 |
| Date Added to Maude | 2011-04-13 |
| 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 6000 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CKA |
| Date Received | 2011-04-13 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| 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 | 2011-04-13 |