MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-25 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[18986379]
The customer reported that they received an erroneous result for one patient sample tested for the mb isoenzyme of creatine kinase stat "short turn around time" (ck-mb stat). The sample initially resulted as 62. 71 ng/ml accompanied by a data flag. This value was reported outside of the laboratory where it was questioned by the doctor. The sample was then repeated and resulted as 1. 25 ng/ml. The repeat value of 1. 25 ng/ml was believed to be correct and the initial result of 62. 71 ng/ml was corrected to the repeat value of 1. 25 ng/ml. The patient was not adversely affected by the event. The ck-mb stat reagent lot number was 16868201 with an expiration date of 04/30/2013. The field service representative determined that the reagent arm had a small leak in the area where the probe is seated. He reseated the connection on the reagent probe. He checked the flowpath for measuring cell 2 where the ck-mb is currently calibrated. He checked the pinch tubes, ran a successful system volume check, ran a successful pmt high voltage check, ran a successful performance check, and ran a successful blank cell calibration on measuring cell 2. The system was turned over to the operator to run quality controls; all controls were ok.
Patient Sequence No: 1, Text Type: D, B5
[19217010]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-04797 |
| MDR Report Key | 2758755 |
| Report Source | 05,06 |
| Date Received | 2012-09-25 |
| Date of Report | 2012-09-25 |
| Date of Event | 2012-09-21 |
| Date Mfgr Received | 2012-09-22 |
| Date Added to Maude | 2012-09-25 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | JLB |
| Date Received | 2012-09-25 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| 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 | 2012-09-25 |