MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-24 for ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT 1N30-90 manufactured by Abbott Molecular, Inc..
[109229419]
Complaint investigation will be performed. Note: lot, expiration, udi, manufacture date and pma number have been left blank as this mdr is being submitted on the basis that abbott realtime hcv amplification reagent kit (list 4j86-90) is similar to the abbott realtime hcv amplification reagent kit (list 1n30-90) sold in the united states. Ticket does not reference a us list 1n30-90 lot number.
Patient Sequence No: 1, Text Type: N, H10
[109229420]
The abbott realtime hcv assay is an in vitro reverse transcription polymerase chain reaction (rt-pcr) assay for the quantitation of hepatitis c viral ribonucleic acid (hcv rna) in human serum and plasma from hcv-infected individuals. The abbott realtime hcv assay is intended for use as an aid in the management of hcv-infected patients undergoing antiviral therapy. The abbott realtime hcv assay is not for screening blood, plasma, serum or tissue donors for hcv, or to be used as a diagnostic test to confirm the presence of hcv infection. Customer called to report a false detected result on the realtime hcv assay. Customer is using our assay for tissue donor screening, which is outside the intended use of the assay per the package insert. Clarification received for claim of second sample in february with similar issue to mdr 3005248192-2018-00004. This case from february was a similar case of running the realtime hcv assay for screening of tissue donors. It is unknown if the result was compared to results received from other laboratories. Customer did not repeat that sample and tissue was discarded based on the detected realtime hcv assay result. The discarding of potential donor tissue due to a false detected result on the realtime hcv assay is regarded as a serious injury due to potential impact on unavailability of tissue for transplant, although the customer used the assay for tissue donor screening, which is outside the intended use of the assay per the package insert. There have been no reports of impact or harm to patient due to this issue. This incident is being reported to fda because the incident occurred in belgium using realtime hcv list number 4j86-90 which is same/similar to us fda approved realtime hcv list number 1n30-90.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00005 |
| MDR Report Key | 7543091 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-24 |
| Date of Report | 2018-06-29 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-05-24 |
| 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 | MR JOE HUTSON |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617619 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT |
| Generic Name | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS |
| Product Code | MZP |
| Date Received | 2018-05-24 |
| Catalog Number | 1N30-90 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-24 |