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 2017-04-03 for ARCHITECT PROLACTIN 07K76-25 manufactured by A.i.d.d Longford.
[71580049]
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
[71580050]
The customer observed falsely depressed prolactin results while using the architect prolactin reagents. The following data was provided. Initial 0. 7 ng/ml. Previous results were higher, 1. 8 ng/ml ((b)(6) 2017) and 2475 ng/ml ((b)(6) 2017). The patient diagnosis is unknown. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[78157370]
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, and field data review. No adverse trend was identified for the customer issue. Labeling was reviewed and found to be adequate. The complaint lot number is unknown. Historical performance of in date lots in the field was evaluated using world wide data from abbott link. The patient data was analyzed and compared to an established control limit. Evaluation indicated that the patient median results for evaluated lots in the field are comparable, are within the established control limits, and no unusual reagent lot performance was identified. A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site. However, a systemic issue and/or product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005094123-2017-00011 |
| MDR Report Key | 6455230 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-03 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2017-04-03 |
| 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 | 2017-04-03 |
| Catalog Number | 07K76-25 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-04-03 |