MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-06 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[3225956]
The customer received questionable results on ck-mb, the mb isoenzyme of creatinine kinase (ck-mb) for one patient sample. All results are in ng/ml. The initial result was (b)(6) and was reported outside of the laboratory. The physician questioned the result and the sample was re-run. The sample was repeated on this instrument and generated a result of "(b)(6) something". The sample was then run on another cobas e601 analyzer and generated a result of (b)(6). This result was issued as the amended result. The customer did not have further information regarding the results. There was no adverse event. The lot of ck-mb reagent in use was 16989801, with an expiration date of 07/31/2013. The field service representative did not find a cause for the issue. He cleaned and checked the flow path and examined the mixing paddle for damage and misalignment. He performed diagnostic and mechanical checks, which passed. The customer performed qc, which also passed.
Patient Sequence No: 1, Text Type: D, B5
[10436330]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10513251]
It was determined on further follow up with the customer that the initial result was 18. 62 ng/ml. The sample was repeated and the result was 18. 6, which was reported out of the laboratory. After the result was questioned by the physician, the sample was repeated on the initial analyzer and generated a "4. Something". The sample was then repeated on the other analyzer and generated a result of 4. 0 ng/ml; which was reported out in an amended report.
Patient Sequence No: 1, Text Type: N, H10
[15749154]
The investigation could not determine a specific root cause. The data provided by the customer was reviewed. The qc results indicated no issue. The alarm trace indicated no issue. It was noted that the 10 minute clotting time for the sample was too short.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-00725 |
| MDR Report Key | 2946145 |
| Report Source | 05,06 |
| Date Received | 2013-02-06 |
| Date of Report | 2013-02-25 |
| Date of Event | 2013-01-18 |
| Date Mfgr Received | 2013-01-22 |
| Date Added to Maude | 2013-02-06 |
| 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 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2013-02-06 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| 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 | 2013-02-06 |