MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-11 for IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) 04784618190 manufactured by Roche Diagnostics.
[90309562]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90309563]
The customer was running a validation study on a newly installed cobas 6000 e 601 module with the elecsys cmv igm immunoassay (cmv igm). The customer was comparing patient samples that had tested positive by the abbott method and running them on the e601 module. During this process, the customer identified a false negative result for 1 patient sample that was reported outside of the laboratory. The initial cmv igm result from the abbott method was 2. 53 coi (positive). The same sample was repeated on the e601 module and the result was 0. 441 coi (negative). On (b)(6) 2017 the sample was sent to an external laboratory using the vidas method and the result was 1. 23 coi (positive) with the recommendation that an avidity test be performed. The customer reported the negative cmv igm result of 0. 441 coi from the e601 module by mistake without waiting for the confirmatory test. There was no allegation that an adverse event occurred. The e601 module serial number was not provided. The patient sample is no longer available for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02249 |
| MDR Report Key | 6939554 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-11 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-09-19 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-11 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2017-10-11 |
| Model Number | NA |
| Catalog Number | 04784618190 |
| Lot Number | 21691601 |
| ID Number | NA |
| Device Expiration Date | 2018-02-28 |
| 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 | 2017-10-11 |