MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-05 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1291497]
The user received erroneous lipase results for four patient samples which were automatically repeated due to data flags. The repeat result for one sample was discrepant. The initial result was 299 u/l with a data flag, the repeat result performed with a dilution was 755 u/l and was reported. On (b) (6) 2010, the sample was repeated four times on the original analyzer with results of 25, 26, 25 and 26 u/l. The sample was also tested on a cobas analyzer at another site and generated a result of 24 u/l. The user called the floor and posted a corrected report of 25 u/l. The patient did not receive any treatment and there were no adverse affects to the patient due to the erroneous result. The lipase reagent lot number was 61448301. It was discovered the user did not have special washes set up for reagent carryover. The technical support specialist assisted the user in programming the special washes. The field service representative determined there was a rinse mechanism malfunction and adjusted the rinse mechanism dispense levels. He cleaned the sample probe and abnormal descent ring, checked the sample and reagent probe alignment, replaced the sample syringe seals, flushed the sample and reagent lines, cleaned the incubation bath and replaced the reaction cuvettes. To verify the analyzer operation, he ran a precision check.
Patient Sequence No: 1, Text Type: D, B5
[8522038]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-01416 |
| MDR Report Key | 1622988 |
| Report Source | 05,06 |
| Date Received | 2010-03-05 |
| Date of Report | 2010-03-05 |
| Date of Event | 2010-02-09 |
| Date Mfgr Received | 2010-02-16 |
| Date Added to Maude | 2010-03-05 |
| 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 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDT |
| Date Received | 2010-03-05 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| 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 | 2010-03-05 |