MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-15 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[139451669]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[139451670]
The customer reported a false repeat reactive abbott prism chagas results. Sample id (b)(6) : (b)(6) year old male, prism chagas repeat reactive and negative on chagas ortho summit assay sample id (b)(6): (b)(6) year old male, prism chagas repeat reactive and negative on chagas ortho summit assay sample id (b)(6): (b)(6) year old male, prism chagas repeat reactive and negative on chagas ortho summit assay no impact to patient/donor management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2019-00010 |
| MDR Report Key | 8344022 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-15 |
| Date of Report | 2019-04-05 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-02-15 |
| 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 | 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 | 3 |
| Brand Name | PRISM CHAGAS |
| Generic Name | CHAGAS |
| Product Code | MIU |
| Date Received | 2019-02-15 |
| Catalog Number | 07K35-68 |
| Lot Number | 89045M500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-15 |