MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-18 for COBAS 6000 CORE 05036453001 manufactured by Roche Diagnostics.
[9671385]
A specific root cause could not be identified. The quality control data do not show any problems with the instrument or reagent. Additional information was not provided for further investigation. No adverse event was reported.
Patient Sequence No: 1, Text Type: N, H10
[21762913]
The customer received a questionable total protein urine/csf gen. 3 (tpuc) result on their c501 analyzer. The analysis was performed on a urine sample using the same c501 analyzer for all tests. The patient's initial tpuc result was 1. 0 mg/dl and it was reported outside the laboratory. The physician questioned the result and the same sample was pulled and re-tested. The patient's first repeat result was 243 mg/dl accompanied by a data flag. The sample was diluted and repeated. The second repeat result was 450 mg/dl. The customer believed the repeat result of 450 mg/dl was correct and it was issued as a corrected report. The patient was not adversely affected by this event. The tpuc reagent lot number was 63545301 and the expiration date was 02/29/2012. The field service representative suspects there was an issue with the patient sample. He was unable to duplicate the issue because the original sample was not available. He inspected the instrument and the customer performed a precision study, which passed.
Patient Sequence No: 1, Text Type: D, B5
[21926749]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05537 |
| MDR Report Key | 2299093 |
| Report Source | 05,06 |
| Date Received | 2011-10-18 |
| Date of Report | 2012-03-09 |
| Date of Event | 2011-09-08 |
| Date Mfgr Received | 2011-09-27 |
| Date Added to Maude | 2011-10-18 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | CEK |
| Date Received | 2011-10-18 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| 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 | 2011-10-18 |