MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-13 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1402420]
Customer reportedly received the following results on the advantage system within 10 minutes: 550 mg/dl and 110 mg/dl. No actions taken based on device results. No adverse event reported. Requested return of suspect device and replacement was sent.
Patient Sequence No: 1, Text Type: D, B5
[1576372]
The user received an erroneous hcg result of 0. 750 miu/ml which was reported to the physician as 0. 800 miu/ml. The physician questioned the result and asked for repeat testing. The same sample was repeated on (b) (6) 2010 and generated a result of 4692 miu/ml with a data flag. The patient was not adversely affected due to the erroneous result. The hcg reagent lot number was 15548403. The field service representative could not determine a specific cause. He installed a replacement measuring cell in channels 1 and 2 as a preventive measure, performed measuring cell replacement procedure and performed an analyzer performance check operation. To verify the analyzer operation, he calibrated and performed qc operation for all onboard assays with results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[8546214]
.
Patient Sequence No: 1, Text Type: N, H10
[8659566]
Investigation of the event determined the customer was not using the recommended tube adaptor on the sample rack. A reagent issue can be excluded because calibration signals and qc results were within specification. An instrument problem was also very unlikely as the customer was doing the recommended maintenance according to the operator manual and performance tests were within the specification. Also, foam or bubbles on the sample or reagent surface have been excluded as a possible cause. The customer was advised to use the recommended adaptor to prevent further false negative results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-02205 |
| MDR Report Key | 1657938 |
| Report Source | 05,06 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-06-03 |
| Date of Event | 2010-03-21 |
| Date Mfgr Received | 2010-03-25 |
| Date Added to Maude | 2010-06-03 |
| 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 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 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NAL |
| Date Received | 2010-04-13 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| 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 | 2010-04-13 |