MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-12-05 for COBAS E411 RACK SYSTEM 04775201001 manufactured by Roche Diagnostics.
[10483973]
The investigation determined the possible root cause could have been too short centrifugation time of 3 minutes. No instrument issues were suspected as assay performance check data was within specifications and instrument checks and alarm data provided no further hints to a cause.
Patient Sequence No: 1, Text Type: N, H10
[20632071]
The fsr reported the customer received a questionable ck-mb - the mb isoenzyme of creatine kinase result for one patient sample that was tested after 10 samples were tested for vitamin d. The initial result was 156. 2 ng/ml with a data flag and was reported outside the laboratory. The patient's physician questioned the result and the laboratory repeated testing. The repeat result was 7. 09 ng/ml with a data flag and a corrected report was issued. There were no adverse effects to the patient. The ck-mb reagent lot number was 16868201 with an expiration date of 04/30/2013. The field service representative could not find a cause and noted the customer repeated the patient sample twice. He checked the system for proper operation and had the customer run precision testing. He verified the system was operating within specifications. The customer ran controls with all results within control limits.
Patient Sequence No: 1, Text Type: D, B5
[21029861]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-06116 |
| MDR Report Key | 2858520 |
| Report Source | 05,06,07 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-12-17 |
| Date of Event | 2012-11-20 |
| Date Mfgr Received | 2012-11-21 |
| Date Added to Maude | 2012-12-05 |
| 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 |
| 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 Country | JA |
| 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 E411 RACK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2012-12-05 |
| Model Number | NA |
| Catalog Number | 04775201001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-12-05 |