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 2018-02-27 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[101468917]
Unique identifier (udi)# (b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[101468918]
The customer complained of questionable results for one patient sample tested for elecsys brahms pct. The patient had three separate samples drawn on three consecutive days. Only one sample had a reportable malfunction when comparing the results from their cobas 6000 e 601 module versus another laboratories abbott analyzer and another laboratories cobas analyzer. The initial pct result was 74. 47 ng/ml. The sample was sent to an outside laboratory and tested on a abbott analyzer with a pct result of 44. 29 ng/ml. The sample was then sent to another outside laboratory and tested on a cobas analyzer on (b)(6) 2018 with a pct result of 49. 60 ng/ml. The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. Control materials that were tested around the same time of event were in acceptable range. The brahms pct reagent lot was 17750601 with an expiration date of 30-apr-2018. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00571 |
| MDR Report Key | 7299079 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-27 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2018-02-27 |
| 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 | PRI |
| Date Received | 2018-02-27 |
| 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 | 2018-02-27 |
| 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 | 2018-02-27 |