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 2011-01-06 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[21351767]
The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21409839]
The user received questionable results for multiple applications on the cobas c501 analyzer. The event involved 16 patient samples. Five samples were discrepant for c-reactive protein (crp), creatinine plus (crep2), albumin (alb) and/or cystatin c (cysc). The samples were repeated on another cobas instrument. Patient sample 1, the initial crp result was 58. 1 mg/l; the repeat result was 26. 1 mg/l. Patient sample 2, (b)(6) female, date of birth (b)(6). The initial crep2 result was 105 umol/l; the repeat result was 66 umol/l. Patient sample 3, (b)(6) female, date of birth (b)(6). The initial alb result was 51 g/l; the repeat result was 38 g/l. Patient sample 4, (b)(6) male, date of birth (b)(6). The initial cysc result was 0. 98 mg/l; the repeat result was 1. 29 mg/l. Patient sample 5, (b)(6) female, date of birth (b)(6). The initial crp result was 253 mg/l; the repeat result was 79. 2 mg/l. The initial results were reported outside the laboratory. From (b)(6) 2010 until (b)(6) 2010 the customer reported the repeat results as corrected reports to the medical doctors for these patient samples. The corrected reports were issued before any of the patients were wrongly treated. No adverse events have been alleged regarding this event. The reagent lot numbers for crp, crep2, alb and cysc were not provided. The field service engineer replaced rinse station tubing, rinse station related valve and reagent probe. No further issues have been reported since service visit. After further investigation an exact root cause could not be identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2011-00070 |
| MDR Report Key | 1950909 |
| Report Source | 01,05,06 |
| Date Received | 2011-01-06 |
| Date of Report | 2011-01-06 |
| Date of Event | 2010-12-10 |
| Date Mfgr Received | 2010-12-13 |
| Date Added to Maude | 2011-04-06 |
| 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 ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NQD |
| Date Received | 2011-01-06 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| 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 | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-06 |