MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TOTAL B-HCG

Catalog Number	07P51-21
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 total b-hcg lots are included in this correction: 92056ui00 and 89203ui00* *list number 07p51-20 is not distributed in the u.S.The fda division has been notified of this product recall.Removals and corrections report number: 3005094123-11/21/ (b)(4) 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, 3005094123-2018-00130, 3005094123-2018-00131, 3005094123-2018-00132 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 89203ui00: manufacture date 08/21/2018, (b)(4).
Event or Problem Description
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.

• Brand Name: ALINITY I TOTAL B-HCG
• Common Device Name: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8097044
• Report Number: 3005094123-2018-00129
• Device Sequence Number: 16650447
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: 00380740160616
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2019
• Device Catalogue Number: 07P51-21
• Device Lot Number: 92056UI00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005094123-11/21/18-002R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY I PROCESSING MODULE, LIST 03R65