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 2016-05-20 for COBAS 8000 E602 MODULE manufactured by Roche Diagnostics.
[45597439]
This event occurred in (b)(6). Unique identifier (udi)#: asku.
Patient Sequence No: 1, Text Type: N, H10
[45597440]
The customer stated that they received questionable results for a total of 11 patient samples tested for free triiodothyronine (ft3) on an e602 analyzer. Of the 11 patient samples, 9 samples had erroneous ft3 results. The erroneous results were not reported outside of the laboratory. It was stated that the repeat run results were reproducible, so the initial results were considered to be erroneously high. Only the initial run and repeat run results were provided. (b)(6). The patients were not adversely affected. The ft3 reagent lot number and expiration date were asked for, but not provided. The field service engineer cleaned, confirmed liquid level detection, confirmed electric pressure and confirmed the position of the sample probe. He cleaned and confirmed the position of reagent and sipper probes. He ran performance testing and measured control material. He did not find any problems with the analyzer and there has been no report of a recurrence of the issue. He noted that the customer was using sample containers which are not recommended for use on the analyzer.
Patient Sequence No: 1, Text Type: D, B5
[48016323]
A specific root cause could not be determined based on the provided information. A general reagent issue could not be detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00666 |
| MDR Report Key | 5669609 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-20 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-05-20 |
| 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 8000 E602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | KHQ |
| Date Received | 2016-05-20 |
| Model Number | E602 |
| Catalog Number | ASKU |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-20 |