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 2017-04-04 for ARCHITECT PROLACTIN 07K76-35 manufactured by A.i.d.d Longford.
[71691263]
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
[71691264]
The customer observed falsely elevated prolactin results while using the architect prolactin reagents. The following data was provided. Initial result 45. 2 ng/ml (951 miu/l), repeat 52. 28 ng/ml, 53. 12 ng/ml results were lower at another facility using another method, approximately 19 ng/ml (400 miu/l), however the method used and the specific value were not provided. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[74528515]
Suspect medical device 4 catalog # should have been 07k76-35 instead of 7k76-25.
Patient Sequence No: 1, Text Type: N, H10
[78157508]
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, device history review, and accuracy testing. No adverse trend was identified for the customer issue. Labeling was reviewed and found to be adequate. Device history review did not identify any issues that may have caused the customer issue. The product was not returned. An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications. Based on all available information and abbott diagnostics evaluation, the assay performed as intended, and a systemic issue and/or product deficiency were not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005094123-2017-00012 |
| MDR Report Key | 6458526 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-04-21 |
| Date Mfgr Received | 2017-04-05 |
| Date Added to Maude | 2017-04-04 |
| 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 | A.I.D.D LONGFORD |
| Manufacturer Street | LISNAMUCK CO. LONGFORD |
| Manufacturer City | LONGFORD NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT PROLACTIN |
| Generic Name | PROLACTIN |
| Product Code | CFT |
| Date Received | 2017-04-04 |
| Catalog Number | 07K76-35 |
| Lot Number | 67336UI00 |
| Device Expiration Date | 2017-08-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.I.D.D LONGFORD |
| Manufacturer Address | LISNAMUCK CO. LONGFORD LONGFORD NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-04 |