MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-02-08 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[15822881]
The investigation could not determine a specific root cause as the sample in question was not available for further testing. It was noted the discrepant result of the undiluted second patient sample is most probably due to the presence of an interferent in the sample. After dilution of the sample, the intereferent was diluted out as well, giving a result as expected.
Patient Sequence No: 1, Text Type: N, H10
[17719636]
The field application specialist reported the user received questionable acetaminophen results for one patient sample. The result from the first sample drawn from the patient was 521 ug/ml after manual dilution. The patient was drawn a second time and the sample was run on the modular p analyzer serial number (b)(4) with a result of 18. 1 ug/ml which was reported outside the laboratory. The technologist questioned the result and repeated testing on the cobas c501 serial number (b)(4) and the result was 17 ug/ml. The user then manually diluted the sample 1:5 and tested it on the modular p analyzer with a result of 244 ug/ml. The user also tested the diluted sample on the cobas c501 and the result was 232. 5 ug/ml the user called the doctor with the corrected report and the patient was not treated based on the incorrect result. The acetaminophen reagent lot number was not provided. The user declined a service visit and stated the results matched with the modular p analyzer and she has not any other issues so she believes this has to do with either the sample or the assay, not a problem with the instrument.
Patient Sequence No: 1, Text Type: D, B5
[17969270]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-00691 |
| MDR Report Key | 1981752 |
| Report Source | 05,06,07 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-04-18 |
| Date of Event | 2011-01-14 |
| Date Mfgr Received | 2011-01-19 |
| Date Added to Maude | 2011-02-08 |
| 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 RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| 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 | LDP |
| Date Received | 2011-02-08 |
| 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 | 2011-02-08 |