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 2016-02-05 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[37619505]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37619506]
The customer questioned high results for 2 oncology patients tested for ferritin. The customer had switched from the ilab 650 turbidimetric method to the e601 analyzer using the electrochemiluminescence method in (b)(6) 2015 and noticed a difference in the results for these 2 patients in (b)(6) 2016. Based on the data provided, the results for 1 patient were erroneous and reported outside of the laboratory with a note that the method had changed. The initial ferritin result from the e601 analyzer was >2000 ng/ml with a data flag. After a manual dilution of 1:50 the repeat result was 32. 77 ng/ml. The calculated result was 1638 ng/ml. This result was reported outside of the laboratory. Since the customer is questioning the ferritin results from the e601 analyzer, they are testing samples using the turbidimetric method on a c501 analyzer. The initial sample was repeated on a different day on the e601 analyzer and the result was 4030 ng/ml. This sample was also repeated on the c501 analyzer and the result was 3569 ng/ml. The customer thinks the results from the c501 analyzer are correct and now believes the results from the e601 analyzer since they are comparable to the c501. The last result from a different sample on the ilab 650 was 962 ng/ml. No adverse event occurred. The ferritin reagent lot number was 187143. The expiration date was not provided.
Patient Sequence No: 1, Text Type: D, B5
[38423876]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A general ferritin reagent issue can be excluded since quality controls were acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00110 |
| MDR Report Key | 5413062 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-05 |
| Date of Report | 2016-02-18 |
| Date of Event | 2016-01-13 |
| Date Mfgr Received | 2016-01-18 |
| Date Added to Maude | 2016-02-05 |
| 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 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2016-02-05 |
| Model Number | E601 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-02-05 |
| Model Number | E601 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-05 |