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 2020-03-10 for ALINITY I SYPHILIS TP REAGENT KIT 07P60-32 manufactured by Abbott Gmbh.
[188030257]
There is no further patient information provided due to privacy issues. 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 7p60-32 that has a similar product distributed in the us, list number 7p60-31.
Patient Sequence No: 1, Text Type: N, H10
[188030258]
The customer reported a (b)(6) alinity i syphilis result of 0. 09 s/co for a patient ((b)(6)). Tpha testing was >1:80 (cutoff <1:80) (b)(6) / immunoblot igg fta if m quant 1:320 (cutoff <1:10) (b)(6). There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00173 |
| MDR Report Key | 9814162 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-10 |
| 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 | 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 I SYPHILIS TP REAGENT KIT |
| Generic Name | ALINITY I SYPHILIS TP |
| Product Code | MTN |
| Date Received | 2020-03-10 |
| Catalog Number | 07P60-32 |
| Lot Number | 10033BE00 |
| 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 | 2020-03-10 |