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 2020-02-13 for ALINITY I SYPHILIS TP REAGENT KIT 07P60-32 manufactured by Abbott Gmbh.
[188029680]
There is no further patient information provided due to privacy issues. Complete information for section a patient information, 1. Patient identifier = (b)(6). 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
[188029681]
The customer reported (b)(6) alinity i syphilis results on one patient. The results provided were: on (b)(6) 2020 (b)(6)= 0. 08s/co (<1. 00s/co = (b)(6) / tpha = >1:80 (cutoff <1:80) (b)(6) / immunoblot igg fta if m quant 1:320 (b)(6) (cutoff <1:10) / retest of sample on a different alinity i analyzer with a different lot = 0. 09s/co. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[188029923]
Suspect medical device, 2. Common device name from alinity i syphilis tp to syphilis. Device manufacturers only, 6. Event problem and evaluation codes: device code from (b)(4). A review of tickets determined normal complaint activity for lot 11057be00, and no trends were identified for the complaint issue. Return testing was not completed as returns were not available. Sensitivity testing was performed with a retained kit of lot 11057be00 and five replicates of positive control. The positive control values met specifications and the results were in the typical range and no false non-reactive results were obtained. Therefore, no unusual reagent lot performance was identified. A review of the manufacturing documentation did not identify any issues associated with the customer's observation. A review of the product labeling concluded that the issue is sufficiently addressed. Based on the investigation no product deficiency was identified for the alinity i syphilis tp reagent, lot 11057be00.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002809144-2020-00110 |
| MDR Report Key | 9705730 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-13 |
| 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 I SYPHILIS TP REAGENT KIT |
| Generic Name | ALINITY I SYPHILIS TP |
| Product Code | MTN |
| Date Received | 2020-02-13 |
| Catalog Number | 07P60-32 |
| Lot Number | 11057BE00 |
| 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 | 2020-02-13 |