MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-11-18 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1724181]
Boston scientific received information that this right ventricular defibrillation lead required repositioning one day post implant due to dislodgement. It was reported that the cause of the lead dislodgement was that the patient actively used her arm after implant against the physician's orders. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[1741918]
The user received questionable nh3l (ammonia) results for two patient samples. Data was provided for one sample that was discrepant. All results are in umol/l. The initial result was 325. 8 with a flag and the repeat result on the cobas c311 analyzer (no serial number provided) was 78. 0. The sample was repeated on the original analyzer and the results were 77. 7 with a flag and 80. 1. No adverse events were alleged regarding the issue. The ammonia reagent lot number was 62961001.
Patient Sequence No: 1, Text Type: D, B5
[8801264]
The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[8868939]
Based on the reaction kinetics for the sample, it was determined the sample either was turbid or somehow colored, so that a regular measurement was not possible. A data flag was generated by the analyzer, notifying the user there may be a problem with the result. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-06805 |
| MDR Report Key | 1901927 |
| Report Source | * |
| Date Received | 2010-11-18 |
| Date of Report | 2011-01-07 |
| Date of Event | 2010-11-03 |
| Date Mfgr Received | 2010-11-03 |
| Date Added to Maude | 2011-01-07 |
| 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 |
| 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 | JIF |
| Date Received | 2010-11-18 |
| 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 | 2010-11-18 |