MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-11-29 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1648530]
The user received a questionable c-reactive protein generation 3 (crp) result for one patient sample. All results are in mg/l. The initial result was 0. 04 and was reported outside the laboratory as < 0. 1 mg/l. The doctor did not believe the result because they had run a crp assay on a near patient testing instrument and received a result of 78. The sample was repeated on another cobas instrument and the result was 79. 87. The patient was not adversely affected. The crp reagent lot number was 63067501.
Patient Sequence No: 1, Text Type: D, B5
[1679525]
It was reported to boston scientific corporation that a sensation micro oval snare was used during a colonoscopy procedure performed on (b)(6), 2010. According to the complainant, the wire in the snare loop broke during the procedure. No part of the snare detached or fell into the patient, and no problems were encountered when removing the device from the patient. The procedure was completed with another sensation micro oval snare. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[8875849]
A specific root cause could not be identified. Further information was not available for investigation. Information provided indicates the sample with the low value was not processed according to the customer's normal routine procedure, which is usually performed on the mpa as the customer had problems with oil in the top serum/plasma layer and gel at the tube walls last year with manually processed samples, the low results may have been caused by preanalytical interference and not by any instrument insufficiency. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
[8900764]
This event ocurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07004 |
| MDR Report Key | 1908674 |
| Report Source | * |
| Date Received | 2010-11-29 |
| Date of Report | 2010-12-22 |
| Date of Event | 2010-11-05 |
| Date Mfgr Received | 2010-11-10 |
| Date Added to Maude | 2010-12-22 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| 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 |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NQD |
| Date Received | 2010-11-29 |
| Catalog Number | 04745914001 |
| 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 INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-29 |