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 2017-07-11 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[80075924]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80075925]
The customer received a questionable high elecsys ferritin result from cobas 6000 e 601 module serial number (b)(4) for one patient sample that was aliquoted by the modular preanalytic analyzer (mpa) serial number (b)(4). The initial result was 75114 mcg/l with a data flag. The repeat result on the same analyzer was 128. 9 mcg/l and the result on another cobas 6000 e 601 module was 126 mcg/l. The erroneous result was reported outside the laboratory. The repeat result was believed to be correct. The patient was not adversely affected. The reagent lot number was 19215405 with an expiration date of 2/28/2018. The field service representative could not find a cause. He straightened the bead mixer, checked the fluidics, and ran precision testing with results within guidelines. Refer to the medwatch with patient identifier (b)(6) for the modular preanalytic analyzer (mpa).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01447 |
| MDR Report Key | 6702927 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-11 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-06-27 |
| Date Mfgr Received | 2017-06-27 |
| Date Added to Maude | 2017-07-11 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2017-07-11 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-11 |
| 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 | 2017-07-11 |