MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-12 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1770571]
A customer received questionable results for multiple assays when testing four patient samples. Results for three of the patients were discrepant. Patient 1, newborn: the initial glucose result was 7 mg/dl. The sample repeated on a different analyzer (serial number unknown) gave 135 mg/dl. The initial alkaline phosphatase result was 6 u/l. The sample repeated on a different analyzer (serial number unknown) gave 57 u/l. The initial total protein result was 0. 4 g/dl. The sample repeated on a different analyzer (serial number unknown) gave 6. 6 g/dl. Patient 2, female newborn: the initial co2 result was 19 mmol/l. The sample repeated on a different analyzer (serial number unknown) gave 28 mmol/l. The initial total protein result was 1. 4 g/dl. The sample repeated on a different analyzer (serial number unknown) gave 4. 1 g/dl. The initial glucose result was 44 mg/dl. The sample repeated on a different analyzer (serial number unknown) gave 71 mg/dl. The initial total bilirubin result was 2. 1 mg/dl. The sample repeated on a different analyzer (serial number unknown) gave 7. 2 mg/dl. The initial alkaline phosphatase result was 200 u/l. The sample repeated on a different analyzer (serial number unknown) gave 571 u/l. The initial phosphorus result was 1. 5 mg/dl. The sample repeated on a different analyzer (serial number unknown) gave 4. 7 mg/dl. Patient 3, male newborn: the initial total bilirubin result was 0. 2 mg/dl. The sample repeated on the same analyzer gave 8. 8 mg/dl. The only initial results reported outside the laboratory were the total bilirubin results for patient 3. The customer had not been informed of any treatment provided, altered or withheld due to the initial results. No adverse events were reported. Reagent lot numbers: co2 628042 total protein 631380 glucose 625902 total bilirubin 62872801 alkaline phosphatase 62762601 phosphorus 627979 the field service representative was unable to reproduce the erroneous results or determine a cause. He inspected instrument sampling and cuvette rinse functions as a preventive measure. The customer ran precision and quality control on all tests involved and the results were within specification.
Patient Sequence No: 1, Text Type: D, B5
[8709621]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-06064 |
| MDR Report Key | 1864575 |
| Report Source | 05,06 |
| Date Received | 2010-10-12 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-09-20 |
| Date Mfgr Received | 2010-09-20 |
| Date Added to Maude | 2010-11-10 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEK |
| Date Received | 2010-10-12 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-10-12 |