MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-23 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[114821734]
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
[114821735]
The customer observed multiple falsely reactive results while using the prism chagas reagents. The following data was provided. Sid numbers were provided and the customer stated repeat reactive specimens did not confirm (confirmatory testing negative), however specific results values were not provided. (b)(4). No impact to patient or donor management were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00113 |
| MDR Report Key | 7711411 |
| Date Received | 2018-07-23 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2018-07-23 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISM CHAGAS |
| Generic Name | CHAGAS |
| Product Code | MIU |
| Date Received | 2018-07-23 |
| Catalog Number | 07K35-68 |
| Lot Number | 83036M500 |
| Device Expiration Date | 2018-10-18 |
| 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 LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |