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 2018-10-08 for ARCHITECT PROLACTIN 07K76-30 manufactured by A.i.d.d Longford.
[125139972]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[125139973]
The customer reported falsely elevated architect prolactin results on one patient. The results provided were: on (b)(6) 2018 = 1250. 21miu/ml (normal range 108. 78-557. 13miu/ml); (b)(6) 2018 new sample at a different hospital tested on siemens = 361. 7miu/ml (normal range 40. 3-530 miu/ml); (b)(6) 2018 sample retested on abbott platform = 819. 04miu/ml; sample was then treated with peg6000 and the result = 243. 44miu/ml. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2018-00063 |
| MDR Report Key | 7943163 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-09-08 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2018-10-08 |
| 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 | 2018-10-08 |
| Catalog Number | 07K76-30 |
| Lot Number | 83068UI00 |
| Device Expiration Date | 2018-12-07 |
| 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 | 2018-10-08 |