MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-17 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1678187]
The user received questionable nh3l (ammonia) results for one patient sample. The original sample was poured into a false bottom tube due to a low sample volume and generated a result of 151 ug/ml. This result was reported outside the laboratory. The same sample in the same false bottom tube was then tested on cobas c501 serial number (b)(4) with a result of 18 ug/ml. The same sample in the same false bottom tube was then put back on the original analyzer and generated a result of 27 ug/ml. This result was sent as a corrective report. The patient was not adversely affected. The ammonia reagent lot number was 61981001. The field service representative determined the cause was unknown. He performed precision and accuracy checks and stated the unit was operational with no errors.
Patient Sequence No: 1, Text Type: D, B5
[8975066]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-06785 |
| MDR Report Key | 1901039 |
| Report Source | 05,06 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-11-17 |
| Date of Event | 2010-11-02 |
| Date Mfgr Received | 2010-11-02 |
| Date Added to Maude | 2010-11-24 |
| 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 | 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 | JIF |
| Date Received | 2010-11-17 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2010-11-17 |