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 2017-03-13 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[69908347]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). Facility name - the full facility name was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[69908348]
The customer stated that they received erroneous results for two patient samples tested for the elecsys digoxin assay (dig) and the elecsys probnp ii immunoassay (probnp) on a cobas 8000 e 602 module (e602). Of the two samples, only the dig result is reportable as a malfunction. The erroneous result was not reported outside of the laboratory. The sample initially resulted as 0. 256 nmol/l accompanied by a data flag. The sample was repeated, resulting as 0. 256 nmol/l accompanied by a data flag. The sample was repeated a second time, resulting as 1. 27 nmol/l. The patient was not adversely affected. The dig reagent lot number was 18991500; the expiration date was not provided. The customer had issues with the sample probe since (b)(6) 2017 and the field service engineer has made adjustments to the probe on (b)(6) 2017. The customer returns to routine testing after evaluation of the control recovery. The liquid level detection voltage was adjusted and the whole sample probe arm was adjusted. The pressure voltage was calibrated. On (b)(6) 2017, the customer received several abnormal sample aspiration alarms. The sample probe arm was then changed. No further issues have been reported since these actions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00545 |
| MDR Report Key | 6398807 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-13 |
| Date of Report | 2017-03-13 |
| Date of Event | 2017-02-05 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-03-13 |
| 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 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | KXT |
| Date Received | 2017-03-13 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-13 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 | 2017-03-13 |