MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for ALINITY I FERRITIN 07P65-30 manufactured by A.i.d.d Longford.
[128216381]
A product recall letter was issued to customers who received shipments of the affected alinity reagents to inform them of the manufacturing issue identified with the reagent cartridge bottle necks. The letter instructs the customer to manually inspect each reagent cartridge in inventory before use. Stat assays, alinity i stat high sensitive troponin- i and alinity i total b-hcg, should be inspected first as a priority to ensure no delay in testing for those assays. The following alinity i ferritin lots are included in this correction: 91532ui00, 93238ui00. The fda division has been notified of this product recall. Removals and corrections report number: 3005094123-11/21/18-002-r. Note: additional products within the scope of this product recall that were distributed in the u. S. Have been filed under mdrs 3005094123-2018-00127, 3005094123-2018-00128, 3005094123-2018-00129, 3005094123-2018-00130, 3005094123-2018-00131 and 3005094123-2018-00133. Impacted products that were not distributed in the u. S. Have also been included in the scope of this field action documentation. Additional lot information: lot 93238ui00: manufacture date: 11/02/2018, expiration date: 09/05/2019.
Patient Sequence No: 1, Text Type: N, H10
[128216382]
Abbott laboratories has become aware of a manufacturing issue that can result in damage to a bottle neck in some reagent cartridges. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the alinity i instrument. When the failure occurs, error codes will be generated which may lead to the potential of delayed patient results. No patient injury has been reported due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2018-00132 |
| MDR Report Key | 8097185 |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-11-16 |
| Device Manufacturer Date | 2018-10-03 |
| Date Added to Maude | 2018-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Removal Correction Number | 3005094123-11/21/18-002R |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALINITY I FERRITIN |
| Generic Name | FERRITIN |
| Product Code | DBF |
| Date Received | 2018-11-21 |
| Catalog Number | 07P65-30 |
| Lot Number | 91532UI00 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-11-21 |