MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for ZIKA VIRUS RNA QUALITATIVE REAL-TIME RT-PCR manufactured by Quest Diagnostics Infectious Disease Inc., San Juan.
[74175727]
On 04/06/2017, quest became aware of the follow product problem: a pregnant woman residing in (b)(6) without known travel outside of (b)(6), without symptoms, had zika virus rna pcr serum testing performed using the focus diagnostic eua approved product. Testing was performed at (b)(6) laboratory reference. Serum was collected on (b)(6) 2017, received by the laboratory 03/30/2017 and "detected" zika rna by pcr reported on 04/02/2017. On 04/06/2017, the (b)(6) contacted the reference laboratory regarding discrepant results using the cdc trioplex uca approved pcr assay, and that additional testing was pending. On 04/17/2017, we were informed that additional testing performed was negative for zika virus infection. The woman and her fetus have had no known adverse events related to this possible false positive zika pcr results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069389 |
| MDR Report Key | 6529514 |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-04-02 |
| Date Added to Maude | 2017-04-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIKA VIRUS RNA QUALITATIVE REAL-TIME RT-PCR |
| Generic Name | ZIKA VIRUS RNA QUALITATIVE REAL-TIME RT-PCR |
| Product Code | POA |
| Date Received | 2017-04-27 |
| Lot Number | 022717KO |
| Device Expiration Date | 2018-02-27 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST DIAGNOSTICS INFECTIOUS DISEASE INC., SAN JUAN |
| Manufacturer Address | CAPISTRANO CA 92675 US 92675 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-27 |