MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-17 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.
[70325119]
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
[70325120]
The customer observed falsely elevated chagas results on the prism analyzer. No specific initial and repeat data was provided for the following sid's: (b)(6) and 4 more samples with no sid provided. The customer observed samples that were repeat reactives on the duplicate retest on chagas, which did not confirm by an alternate method/supplemental test (test date (b)(6) 2017). There was no impact to patient management reported, however the 13 blood donors were deferred.
Patient Sequence No: 1, Text Type: D, B5
[71600115]
An evaluation is still in process. A final report will be submitted when the evaluation is complete. See also additional reports for the same data with different suspect medical device in use: manufacturers report number 1415939-2017-00023 for lot 70056m500, manufacturers report number 1415939-2017-00027 for lot 70116m500.
Patient Sequence No: 1, Text Type: N, H10
[71600116]
Additional information was provided on march 20, 2017. Five (5) additional prism analyzers were in use with the same likely causes (suspect medical device) sn (b)(4). Specific data was also provided: (b)(6). All the units were t. Cruzi (chagas) negative using a supplemental method, with the exception of (b)(6) that returned an intermediate result.
Patient Sequence No: 1, Text Type: D, B5
[73132549]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and specificity testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. Clinical specificity testing of negative control replicates was performed using in-house retained kits stored at the recommended storage condition. Specificity testing met all specifications. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2017-00022 |
| MDR Report Key | 6414921 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-17 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-04-05 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-03-17 |
| 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 | 2017-03-17 |
| Catalog Number | 07K35-68 |
| Lot Number | 68048M500 |
| Device Expiration Date | 2017-06-25 |
| 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 | 2017-03-17 |