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 2020-01-15 for ALINITY I SYPHILIS TP REAGENT KIT 07P60-77 manufactured by Abbott Gmbh.
[188028489]
Patient information: no further patient information was provided by the customer. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[188028490]
The customer observed a (b)(6) alinity i syphilis tp result for (b)(6) female patient. The following data was provided: on (b)(4) 2020 (b)(4) initial result = 0. 54 (b)(6)), colloidal gold = (b)(6), elisa = (b)(6), patient was positive a year ago with chemiluminescence and elisa testing. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[188028687]
A review of tickets was performed for reagent lot number 03516be01. The ticket search determined that there is normal complaint activity for the likely cause lot. A review of tracking and trending did not identify any trends for the complaint issue. Return testing was not completed as returns were not available. Retained reagent kits of lot number 03516be00 (which contains the same bulk material as 03516be01) were tested in a sensitivity setup, including additional replicates of positive control. Results of this setup were in typical range and no false non-reactive results were obtained. Additionally, the architect syphilis tp reagent, lot number 03540be00 (which contains identical bulk reagents) was also tested as this test setup includes testing of a sensitivity panel. This included additional replicates of the testing panel. Results of this setup were in typical range and no false non-reactive results were obtained. All generated data demonstrate that the performance of the alinity i syphilis tp reagent, lot number 03516be00 is not compromised. A review of the manufacturing documentation did not identify any issues associated with the complaint issue. A review of labeling concluded that the issue is sufficiently addressed. Based on the investigation no systemic issue or deficiency of the alinity i syphilis tp assay for lot 03516be01 was identified. This report is being filed on an international product, list number 7p60-32 that has a similar product distributed in the us, list number 7p60-21/31.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002809144-2020-00043 |
| MDR Report Key | 9590439 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-08-06 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Catalog Number | 07P60-77 |
| Lot Number | 03516BE01 |
| Device Expiration Date | 2020-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-15 |