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 2018-07-19 for ARCHITECT PROLACTIN 07K76-25 manufactured by A.i.d.d Longford.
[114810301]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Patient information, no further patient information was provided.
Patient Sequence No: 1, Text Type: N, H10
[114810302]
The customer reported a falsely depressed architect prolactin result for a patient with a large pituitary tumor (prolactinoma). Sample id (b)(4) generated a result of 106. 5 miu/l which the customer believed was lower than expected based on the patient's clinical picture. The customer further tested the sample with multiple dilutions including 1:10 autodilution and manual dilutions with multi-assay diluent as recommended by the package insert. All dilutions generated results below the reportable limit. The sample was further evaluated with multiple dilutions using a serum sample with a low prolactin (22. 6 miu/l). The results ranged from 125. 8 miu/l with a 1:2 dilution to 28701. 6 miu/l with a 1:1200 dilution. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2018-00024 |
| MDR Report Key | 7702977 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-07-19 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2018-01-23 |
| Date Added to Maude | 2018-07-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-07-19 |
| Catalog Number | 07K76-25 |
| Lot Number | 84028UI00 |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-07-19 |