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 2017-06-16 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[77868757]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77868758]
The customer complained of false positive results for 1 patient tested for elecsys (b)(6) and elecsys toxo igg immunoassay (toxo igg). This medwatch will cover (b)(6). Refer to medwatch with patient identifier (b)(6) for information on the toxo igg erroneous results. On (b)(6) 2017 the patient had a toxo igg result that was negative (the actual result was not provided) and a (b)(6) result that was (b)(6) (the actual result was not provided). On (b)(6) 2017 a new sample was obtained and the (b)(6) result was 134. 5 u/ml ((b)(6)). The sample was repeated and the result was 134. 4 u/ml (positive). The toxo igg result was 164. 0 iu/ml (positive). The sample was repeated and the result was 165. 5 iu/ml ((b)(6)). These results were reported outside of the laboratory. On (b)(6) 2017 the initial sample from (b)(6) 2017 was repeated and the (b)(6) result was 0. 150 u/ml with a data flag ((b)(6)) and the toxoplasma igg result was 0. 130 iu/ml with a data flag (negative). A new sample was obtained on (b)(6) 2017 and the patient? S (b)(6) result was 0. 150 u/ml ((b)(6)) and the patient? S toxoplasma igg result was 0. 130 iu/ml (negative). No adverse event was reported. The instrument type and serial number were not provided. The customer has excluded a sample mix up or a preanalytic issue because she measured each of the 3 samples from the patient and confirmed the results herself.
Patient Sequence No: 1, Text Type: D, B5
[132598439]
The patient samples from (b)(6) 2017 and (b)(6) 2017 were submitted for investigation. The samples were tested using various methods: elecsys cmv igg, elecsys cmv igg avidity, recomline cmv igg, elecsys toxo igg, an in-house neutralization assay, elecsys toxo igg avidity and recomline toxo igg. The results using the various methods were reproducible. The (b)(6) 2017 sample showed clear reactivity using the elecsys cmv igg assay. The detected antibodies were of high avidity and reactivity. This suggests that cmv directed antibodies were present in the sample. This is additionally supported by the recomline cmv assay results. The sample from (b)(6) 2017 was confirmed to be non-reactive for all cmv assays. Based on investigations performed, the cmv igg and toxo igg results for both samples are considered to be correct. The reactivity pattern of the samples over the course of 6 days does not correspond to a humoral immune response. A specific root cause was not identified. Possible root causes may be related to sample contamination or a sample mix-up. Both reagents perform within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01247 |
| MDR Report Key | 6646180 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-16 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-05-30 |
| Date Added to Maude | 2017-06-16 |
| 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 |
| 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 | 2017-06-16 |
| Model Number | NA |
| Catalog Number | 04784596190 |
| Lot Number | 174473 |
| 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 | 2017-06-16 |