MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-11 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[45050192]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45050193]
The customer complained of questionable results for one blood sample while testing for elecsys ferritin (ferritin). It was stated that they received a result of 0. 515 ng/ml without any flags on an aliquoted tube on cell 1. They reran the sample and got 695. 1 ng/ml without any flags on the same aliquoted sample on the same cell. They reran the primary tube on cell 2 and obtained a value of 728 ng/ml. All of these results were from the same analyzer. They originally reported the 0. 515 ng/ml result but they "caught it almost immediately and reran it and reported the 695. 1 ng/ml. They believed the 695. 1 value to be the correct result. " there was no adverse event. The reagent is lot number 18714303 with an expiration date of 10/31/2016. The field service representative visit found no cause for the results. A general reagent issue cannot be seen based on the provided quality control data. The instrument was checked and successful performance testing was done. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-00626 |
| MDR Report Key | 5648409 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-11 |
| Date of Report | 2016-05-11 |
| Date of Event | 2016-04-23 |
| Date Mfgr Received | 2016-04-25 |
| Date Added to Maude | 2016-05-11 |
| 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 | 2016-05-11 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-05-11 |
| Model Number | E601 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-11 |