MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-14 for COBAS 8000 E 602 MODULE E602 manufactured by Roche Diagnostics.
[72956343]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[72956344]
The customer received a questionable elecsys ferritin result for one patient sample. The initial result was 88. 80 ug/l and was reported outside the laboratory. The clinician did not agree with this result compared to the other biological and clinical tests performed. The patient was redrawn on (b)(6) 2017 and the result for this sample was 18. 84 ug/l. The result from another cobas 8000 e 602 module was 19. 05 ug/l. These results matched the other tests performed. The sample from (b)(6) 2017 was then repeated and the results were 46. 18 ug/l and 37. 29 ug/l. The results from the other cobas 8000 e 602 module were 35. 16 ug/l and 35. 82 ug/l. There was no allegation of an adverse event. The reagent lot number was 192154. The expiration date was requested but was not provided. The laboratory confirmed there was no mix up of the sample identification as all other parameters gave the same results.
Patient Sequence No: 1, Text Type: D, B5
[76647609]
A specific root cause could not be determined. The most likely root cause was a preanalytical issue such as a centrifuge with a too high speed or a too short clotting time. These issues would result in clot formation in the sample and affect the sample quality. Other possible causes include insufficient maintenance or contamination of the environment with the analyte. The differences between the results from the different draw dates are very likely due to an unknown clinical status of the patient or due to medication. A general reagent issue was not suspected based on the provided qc data.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00779 |
| MDR Report Key | 6493783 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-14 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-03-15 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2017-04-14 |
| Model Number | E602 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-14 |
| Model Number | E602 |
| Catalog Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-14 |