MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for LIGHTMIX ZIKA RRT-PCR TEST (EUA) 07987897001 manufactured by Olfert Landt, Tib Molbiol Syntheselabor Gmbh.
[69804608]
The investigation into the generation of the false positive results and drifting baselines is currently on-going. A supplemental report will be provided at the end of the investigation. Roche molecular systems holds the eua for the product. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69804609]
The customer in (b)(6) is observing a baseline drift in the target pcr curve, which is raising the fluorescence intensity ratio (fir) for presumed, negative samples (serum) to be close to or above the 10 percent cut-off value indicated in the lightmix zika rrt-pcr test, eua instructions for use. Per the instructions for use, when the fir is >/= 10 percent, the result for the zika assay is considered valid and the interpretation of the specimen is positive for zika virus. The customer is only running serum samples. The customer site is testing clinical samples and is only reporting negative results, where the pcr growth curves do not have a cp value and no associated growth curve, and positive results, where the pcr growth curves are sigmoidal in shape. There is no indication of harm or injury, to date, as a result of the alleged false positive zika results.
Patient Sequence No: 1, Text Type: D, B5
[75535729]
The customer in the united states alleged the generation of false positive when testing presumed negative samples with the lightmix zika rrt-pcr test, eua, following the instructions for use and the fluorescence intensity ratio (fir). Per the instructions for use, when the fir is >/= 10 percent, the result for the zika assay is considered valid and the interpretation of the specimen is positive for zika virus. The customer confirmed that they were testing clinical samples; however, the false positive issue did not occur during patient testing but was observed during their validation testing. As this customer and another (reported in a separate medical device report: 2243471-2017-00004) were generating false positive results with the implementation of the fir, roche informed customers to discontinue use and discard any remaining inventory of the lightmix zika rrt-pcr test, eua. Additionally, roche requested to the u. S. Food and drug administration (fda) to withdraw this test. On 13-mar-2017, roche received the fda's notice of revocation. A capa was initiated to identify the root cause for the false positive results and drifting baseline. Corrective and preventive measures will be implemented as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2017-00005 |
| MDR Report Key | 6392444 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-05-08 |
| Date of Event | 2016-01-25 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-03-09 |
| 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 TIMOTHY BLAIR |
| Manufacturer Street | 1080 US HIGHWAY 202 SOUTH NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537918 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTMIX ZIKA RRT-PCR TEST (EUA) |
| Generic Name | REAGENTS, ZIKA VIRUS NUCLEIC ACID |
| Product Code | POA |
| Date Received | 2017-03-09 |
| Model Number | NA |
| Catalog Number | 07987897001 |
| Lot Number | 38161612 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLFERT LANDT, TIB MOLBIOL SYNTHESELABOR GMBH |
| Manufacturer Address | ERESBURGSTR. 22-23 NA BERLIN 12103 12103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-09 |