MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-15 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[59976370]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10
[59976371]
The customer indicated an increase in reactive results has been generated while using the prism chagas assay on the prism 6 channel analyzer. During the timeframe of (b)(6) 2016 to (b)(6) 2016, twelve specimens which had been repeat reactive were negative when tested using the ortho method. Specifically the customer indicated that false positive results were generated on (b)(6) 2016 and (b)(6) 2016 using lot 60017m500. No specific patient data has been provided. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[63636710]
Further investigation of the customer issue included a review of the complaint text, in-house testing, a device history review, a search for similar complaints, and a review of labeling. Return material was not available from the customer. A specificity testing protocol was executed using lot 60017m500 and met acceptance criteria and determined the reagent is performing acceptably. The device history review did not identify any non-conformances or deviations related to the customer's observations. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the prism chagas reagent, list number (b)(4), lot number 60017m500, was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00112 |
| MDR Report Key | 6103038 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-15 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-07-10 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2016-11-15 |
| 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 |
| 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 | 2016-11-15 |
| Catalog Number | 07K35-68 |
| Lot Number | 60017M500 |
| Device Expiration Date | 2016-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-11-15 |