MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number 07P4820

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Complete entry = (b)(6).Patient information: no further information was provided.An evaluation is in process.A follow up will be provided when the investigation is complete.

Event Description

The customer obtained a falsely depressed alinity i tsh result.Sample on (b)(6) 2021 sample id (b)(6) generated initial 0.05 miu/l; retest of same sample in cup 0.17 miu/l: retest second sample 0.19 miu/l.No impact to patient management was reported.

Event Description

The customer provided the following additional falsely depressed alinity i tsh results: (b)(6) 2021 sample id (b)(6) : 0.10 miu/ml; retest 2.18 miu/ml.

Manufacturer Narrative

The customer provided an additional falsely depressed patient result.Section b5 was updated to include the additional falsely depressed result.Section a1 was updated to multiple.Multiple = (b)(6).The investigation included review of the information provided by the customer, complaint data, trending data, labeling and device history records.In-house testing of the complaint lots was also completed.Return testing was not completed as returns were not available.Review of complaint trending reports for the alinity i tsh assay did not identify any trends for the complaint issue.Device history records for the complaint lots were reviewed and did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Accuracy testing was completed using panels which mimic patient samples and an in-house retained kit of lot 28117ud00 stored at the recommended storage condition.Lot 28117ud00 was a second lot in use at the customer site.All specifications were met indicating that the lot is performing acceptably.Based on this investigation, no systemic issue or deficiency of the alinity i tsh assay was identified.

• Brand Name: ALINITY I TSH REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 12529875
• MDR Text Key: 273602968
• Report Number: 3005094123-2021-00183
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• Combination Product (y/n): N
• PMA/PMN Number: K983442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: 07P4820
• Device Catalogue Number: 07P48-20
• Device Lot Number: 28376UD00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)