MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-11 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1402225]
The user alleged 5 patient samples had erratic recovery for total protein (tp) and albumin (alb). The user stated all other tests running fine. Results for 3 patient samples were provided which were discrepant for tp and or alb. Sample 1, initial tp gave 0. 0; repeat gave 7. 0 g/dl. Sample 2, female, (b) (6), initial tp gave 2. 0 g/dl. This result was reported outside the laboratory. The doctor questioned the result and requested the sample be repeated. Repeat tp gave 7. 6 g/dl. User said the patient was not treated based on the initial result reported. Sample 3, female, (b) (6), initial albumin gave - 0. 2; repeat gave 4. 1 g/dl. Erroneous results were reported outside of the laboratory for sample 2 only. The patients were not adversely affected. Tp reagent lot number - 61868401. Alb reagent lot number - 61870001 the field service representative determined specimen preparation by customer, likely a clot, caused the discrepant results. In addition he noted a sample clot instrument alarm was generated for the specimen in questioned. He verified fluidics and mechanical alignments were good with no change. Upon his arrival, customer had performed a probe wash for the sample clot error and ran controls which recovered within range. Customer successfully ran calibration and controls. He ran a precision study to verify analyzer was performing within specification. No further problems have been reported.
Patient Sequence No: 1, Text Type: D, B5
[8654610]
It is unknown if initial reporter sent report to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-03532 |
| MDR Report Key | 1720020 |
| Report Source | 05,06 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-06-11 |
| Date of Event | 2010-06-03 |
| Date Mfgr Received | 2010-06-03 |
| Date Added to Maude | 2010-06-11 |
| 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 | CEK |
| Date Received | 2010-06-11 |
| 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 | 2010-06-11 |