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 2017-05-22 for ARCHITECT PROLACTIN 07K76-30 manufactured by A.i.d.d Longford.
[75723204]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[75723205]
The customer observed falsely elevated prolactin results for one patient while using the architect prolactin reagents. The following data was provided. The customer uses reference range 5. 18 to 26. 53 ng/ml. Initial 95. 11, repeat 98. 6, 7. 98 siemens method was lower, 19. 9 ng/ml (reference range 2. 8 to 29. 2 ng/ml). No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[77562269]
Suspect medical device 4 catalog # should have been 07k76-30 instead of 7k76-35. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005094123-2017-00027 |
| MDR Report Key | 6583401 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-22 |
| Date of Report | 2017-08-23 |
| Date Mfgr Received | 2017-08-23 |
| Device Manufacturer Date | 2017-01-04 |
| Date Added to Maude | 2017-05-22 |
| 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 | 2017-05-22 |
| Catalog Number | 07K76-30 |
| Lot Number | 71208UI00 |
| Device Expiration Date | 2017-12-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-05-22 |