MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-26 for ALINITY S ANTI-HCV REAGENT KIT 06P04-55 manufactured by Abbott Gmbh.
[185107596]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 06p04-55 that has a similar product distributed in the us, list number 06p04-60. Complete information section a, 1. Patient identifier = 102720001689. There was no additional patient information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[185107597]
The customer reported false reactive alinity s anti-hcv results on one donor. The results provided were: on 04mar2020 sid102720001689 =0. 97s/co (<1. 00s/co = nonreactive) on alinitys serial number (sn) (b)(4). The customer did not like the result being close to the cutoff, so on 05mar2020 the sample was retested on alinity s sn (b)(4) and the results =1. 20s/co (>1. 00s/co = reactive) / retest = 0. 98 and 1. 10s/co. The sample was sent and tested by nat and realtime pcr with both being negative. There was no reported impact to donor management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00218 |
| MDR Report Key | 9884212 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT GMBH |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALINITY S ANTI-HCV REAGENT KIT |
| Generic Name | ANTI-HCV |
| Product Code | MZO |
| Date Received | 2020-03-26 |
| Catalog Number | 06P04-55 |
| Lot Number | 09221BE00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GMBH |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |