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 2019-05-15 for ELECSYS CMV IGM IMMUNOASSAY 04784618190 manufactured by Roche Diagnostics.
[145103703]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145103704]
The initial reporter complained of (b)(6) results for 1 patient sample tested for elecsys cmv igm immunoassay (cmv igm) on a cobas 6000 e 601 module. The initial result from the e601 module was (b)(6). This result was reported outside of the laboratory. On (b)(6) 2019 a different tube drawn at the same time as the original was repeated on the e601 module with a result of (b)(6). The sample was tested by the mini vidas method and the result (b)(6). The patient was also tested at a different laboratory using the abbott architect method and the result was "(b)(6). " the actual result was not provided. There was no allegation that an adverse event occurred. The e601 module serial number was (b)(4). Pinch tubes were last replaced on 11-mar-2019. Liquid flow cleaning was last performed on 26-apr-2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01834 |
| MDR Report Key | 8611409 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-15 |
| Date of Report | 2019-08-06 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS CMV IGM IMMUNOASSAY |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2019-05-15 |
| Model Number | NA |
| Catalog Number | 04784618190 |
| Lot Number | 33605600 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2019-05-15 |