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 2017-07-20 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[80789470]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80789491]
The customer received a questionable elecsys ferritin result for one patient sample. The initial result was 1. 02 ng/ml and the repeat result was 39. 94 ng/ml. The initial 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 20990805 with an expiration date of 5/31/2018. The field service representative flushed the reagent probe, checked and cleaned the bead mixer and sipper probe, and visually inspected measuring cell. The customer ran calibration and qc. No abnormal trends were identified for this issue. The customer has had no other complaints of this nature on a like analyzer in the past 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01506 |
| MDR Report Key | 6728024 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-20 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-06-30 |
| Date Added to Maude | 2017-07-20 |
| 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 | 2017-07-20 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-07-20 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-07-20 |