MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-03 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[19685745]
User reported out an erroneous alt result of 536 u/l for one patient sample. Sample type is plasma. Erroneous result was generated from a sample aliquotted by an mpa system. On (b) (6) 2010, the physician questioned the result and requested the patient be redrawn. The redrawn sample gave 14 u/l. On (b) (6) 2010 the original primary sample tube was repeated on another c501 analyzer serial number 75202 at the site giving 14 u/l. Physician did not act on the erroneous alt result reported. Patient was not adversely affected. Alt reagent lot number, 61893401 the field service representative found the sample probe was misadjusted. He adjusted the sample probe. To verify analyzer performance a precision study was run with no issues.
Patient Sequence No: 1, Text Type: D, B5
[19749326]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-00748 |
| MDR Report Key | 1593245 |
| Report Source | 05,06 |
| Date Received | 2010-02-03 |
| Date of Report | 2010-02-03 |
| Date of Event | 2010-01-11 |
| Date Facility Aware | 2010-01-13 |
| Date Mfgr Received | 2010-01-13 |
| Date Added to Maude | 2010-02-03 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | CJJ |
| Date Received | 2010-02-03 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2010-02-03 |