MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-28 for ARCHITECT PROLACTIN 07K76-25 manufactured by A.i.d.d Longford.
[132386992]
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
[132386993]
The customer reported falsely elevated architect prolactin results on one patient. The results provided were: (b)(6) 2017 = 44. 3ng/ml / 05oct2018 = 69. 9ng/ml / 26nov2018 = 57. 6ng/ml / patient redrawn on 30nov2018 and sample sent out - beckman dxi = 9. 27ng/ml (normal range = 3. 24-27. 2ng/ml); mayo roche cobas macroprolactin = 5. 8ng/ml and total prolactin = 24. 9ng/ml (normal range = 4. 8-23. 3ng/ml). There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2018-00284 |
| MDR Report Key | 8204314 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2018-08-09 |
| Date Added to Maude | 2018-12-28 |
| 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 | 2018-12-28 |
| Catalog Number | 07K76-25 |
| Lot Number | 91148UI00 |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-28 |