MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for ARCHITECT PROLACTIN 07K76-25 manufactured by A.i.d.d Longford.
[52837184]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52837285]
The customer observed a falsely elevated prolactin result on the architect i2000sr analyzer. The following data was provided: initial 55 ng/ml. The sample was sent to a reference lab and the result was 23. 8 ng/ml. The patient underwent a negative mri procedure of her pituitary gland due to the high architect prolactin result. Multiple attempts to get more patient information were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[56122979]
The complaint trending report review determined that there are no non statistical or adverse trends for the product for the complaint issue. As the likely cause lot number in this case is unknown, testing, lot and device history record reviews could not be performed. To further evaluate the customer's issue, the historical performance in the field of reagent lots using worldwide data through abbottlink was performed. The review showed that although an upward shift in patient median results was observed followed by a downward shift, all within date lots are within +/- 2sd of the mean confirming no systemic issue with any in date lot. Statistical process control chart (spc) analysis was performed for the architect prolactin assay. All lots were within specification and no trends were observed for controls and panels across reagent lots that could potentially be related to the customer's issue. Review of external proficiency (ukneqas) data for the previous 12 months shows all results are within acceptable limits and no performance issues were highlighted for the prolactin assay. The ukneqas macroprolactin survey concluded that identifying patients with apparent hyperprolactinemia attributable to macroprolactin (i. E. High "total" prolactin but normal monomeric prolactin) is desirable to minimise the risk of unnecessary clinical investigation, in particular mri scans. The extent of recognition of macroprolactin depends both on the immunoassay method used and on the nature of the particular macroprolactin present. No method has been shown to lack cross-reactivity with macroprolactin in every case and all methods have been shown to recognise macroprolactin on occasion. A review of the product labeling concluded that the issue is sufficiently addressed, including information that prolactin may exist in alternate structural forms (e. G. , macroprolactin) which may exhibit variable levels of physiological activity. In patients with elevated prolactin results, additional information may be required for diagnosis. Based on all available information the assay performed as intended.
Patient Sequence No: 1, Text Type: N, H10
[78157142]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site. However, no systemic issue and/or product deficiency was identified. The conclusion code was changed from (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005094123-2016-00043 |
| MDR Report Key | 5898822 |
| Date Received | 2016-08-23 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-06-28 |
| Date Mfgr Received | 2016-09-18 |
| Date Added to Maude | 2016-08-23 |
| 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 | 2016-08-23 |
| Catalog Number | 07K76-25 |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2016-08-23 |