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 2018-05-18 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 07027117190 manufactured by Roche Diagnostics.
[109238059]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). Facility name - the full facility name was provided as "(b)(4)". (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109238060]
The customer stated that they received erroneous high results for two samples from the same patient tested for the elecsys cmv igg assay (cmvigg) on a cobas 8000 e 801 module (e801). The medical doctor in charge and they gynecologist in charge were informed of the erroneous values. The customer suspected that the samples contain an interferent to the cmvigg assay. A sample from the patient collected on (b)(6) 2017 resulted with a negative cmvigg value when tested on a cobas 8000 e 602 module. A second sample was collected from the patient on (b)(6) 2018 and tested for cmvigg on the e801 analyzer, resulting with a value of 4. 02 iu/ml (positive). A third sample was collected from the patient at a different laboratory on (b)(6) 2018 and measured for cmvigg using the diasorin liaison method, resulting as < 5. 0 u/ml (negative). This sample also resulted as < 5. 0 u/ml (negative) when tested with the diasorin liaison cytomegalovirus igm (cmvigm) method. A fourth sample was collected from the patient on (b)(6) 2018 and tested for cmvigg on the e801 analyzer, resulting with a value of 3. 95 iu/ml (positive). An aliquot of this sample was sent to another laboratory where it resulted with a cmvigm value of < 0. 85 index (negative). No adverse events were alleged to have occurred with the patient. The e801 analyzer serial number was (b)(4). The fourth patient sample was provided for investigation. The results obtained by the customer could be duplicated. A general reagent issue could be excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01555 |
| MDR Report Key | 7525900 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-18 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-05-18 |
| 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 | CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2018-05-18 |
| Model Number | NA |
| Catalog Number | 07027117190 |
| Lot Number | 252325 |
| 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 | 2018-05-18 |