MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT 1N30-90 manufactured by Abbott Molecular, Inc..
[109239927]
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
[109239928]
The abbott realtime hcv assay is an in vitro reverse transcription polymerase chain reaction (rt-pcr) assay for the quantitation of (b)(6) in human serum and plasma from (b)(6) individuals. The abbott realtime hcv assay is intended for use as an aid in the management of (b)(6) patients undergoing (b)(6) therapy. The abbott realtime hcv assay is not for screening blood, plasma, serum or tissue donors for (b)(6), or to be used as a diagnostic test to confirm the presence of (b)(6) infection. Customer called to report a (b)(6) 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. Serum was tested from person as organ donor, and found (b)(6) in 2 other labs: organs were transplanted. The same serum was tested at our customer site from this person as a tissue donor, but found detected, so tissue was discarded. Both other labs were very surprised but certainly anxious to have given an (b)(6) organ to someone. Two (2) new samples (1 serum (b)(6) and 1 plasma (b)(6)) were tested in the 3 labs and all were not detected/ (b)(6). Serology was (b)(6) for (b)(6). Sample (b)(6) serum generated a (b)(6) (detected) result when run on the realtime hcv assay. Sample (b)(6) serum generated a not detected. Sample (b)(6) plasma had an internal control failure. When the customer repeated all samples on (b)(6), all were not detected. The discarding of potential donor tissue due to a (b)(6) 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 (b)(6) 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 | 3005248192-2018-00004 |
| MDR Report Key | 7543089 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-06-29 |
| Date of Event | 2017-03-01 |
| 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 | 0 |
| 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 |