MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-09 for COBAS 6000 CORE 04745868001 manufactured by Roche Diagnostics.
[19904725]
The user received questionable acetaminophen results for one patient sample. The original result was 182. 4 ug/ml with a data flag and was reported outside the laboratory. The result was questioned and a redraw of the patient was ordered. The original sample was retested twice and the result was -4. 1 ug/ml with a data flag each time. On (b)(6) 2010, the patient was redrawn. The original result was -4. 3 ug/ml with a data flag and the repeat result was -4. 1 ug/ml with a data flag. The result was reported outside the laboratory as <1. 2 ug/ml. The original sample was tested on cobas c501 analyzer serial number (b)(4) and the result was -4. 3 ug/ml with a data flag. The second (redraw) sample was tested on cobas c501 analyzer serial number (b)(4) and the result was -4. 0 ug/ml with a data flag. The patient was not adversely affected and was not treated based on the original result. The acetaminophen reagent lot number was 62893701. The field service representative determined there was problem with one of the valves and cleaned it. To verify the analyzer operation, he ran precision testing.
Patient Sequence No: 1, Text Type: D, B5
[20112016]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07260 |
| MDR Report Key | 1917611 |
| Report Source | 05,06 |
| Date Received | 2010-12-09 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-11-23 |
| Date Mfgr Received | 2010-11-24 |
| Date Added to Maude | 2011-04-07 |
| 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 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LDP |
| Date Received | 2010-12-09 |
| Model Number | NA |
| Catalog Number | 04745868001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2010-12-09 |