MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-05-14 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1550632]
Customer received "fliers" beginning 5/2/10 for multiple assays. The following patient results were provided by customer: patient 1, initial total protein result 1. 1 (accompanied by data flags), repeated on another cobas analyzer gave 6. 5 g/dl. The 6. 5 g/dl total protein result was reported. Patient 2, female, (b) (6), testing (b) (6) 2010, initial glucose result 7 mg/dl (accompanied by data flags), repeated three times gave 87 (another cobas analyzer), 88 (blood gas analyzer), and 86 mg/dl (original analyzer). The 87 mg/dl glucose result was reported; initial sodium result 132 mmol/l (accompanied by data flags), repeated twice gave 135 (another cobas analyzer) and 141 mmol/l (blood gas analyzer, different methodology). Customer stated the aberrant results were not sent to the floor, only the correct results were reported. Reagent lot #s: glucose 61943801 total protein 62112501 sodium electrode lot not provided the field service representative found a misadjusted sample line caused poor sampling and he adjusted the sample line. Customer ran samples with no further issues.
Patient Sequence No: 1, Text Type: D, B5
[8647266]
It is unknown if initial reporter sent report to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-02923 |
| MDR Report Key | 1689556 |
| Report Source | 05,06 |
| Date Received | 2010-05-14 |
| Date of Report | 2010-05-14 |
| Date of Event | 2010-05-02 |
| Date Mfgr Received | 2010-05-05 |
| Date Added to Maude | 2010-05-14 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEK |
| Date Received | 2010-05-14 |
| 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 | 2010-05-14 |