MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number 07P51-30

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

Emdr: this report is being filed on an international product list 07p51-30, that has a similar us product distributed in the us, list 7p51-21 / 31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The account observed inconsistent alinity i total bhcg results with a female patient sample.(b)(6) (pregnancy location unknown with query of ectopic) tested positive of 36, 44 iu/l and negative of <2, <2 iu/l.Additional 8 replicates were negative of <2 iu/l on another alinity analyzer.No additional patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

Section a.Patient age, race ethnicity provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed to alinity i processing module, list 03r65-01 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2022-00187.All further information will be documented under mdr number 3016438761-2022-00187.After further evaluation, the suspect medical device was changed to alinity i processing module, list 03r65-01 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2022-00187.All further information will be documented under mdr number 3016438761-2022-00187.

Event Description

The account observed inconsistent alinity i total bhcg results with a female patient sample.Sid (b)(6) (pregnancy location unknown with query of ectopic) tested positive of 36, 44 iu/l and negative of <2, <2 iu/l.Additional 8 replicates were negative of <2 iu/l on another alinity analyzer.No additional patient information was provided.Additional information provided.Patient is 21 year old female, black race.No impact to patient management was reported.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13796076
• MDR Text Key: 287339416
• Report Number: 3005094123-2022-00049
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Catalogue Number: 07P51-30
• Device Lot Number: 31373UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI01105; ALNTY I PROCESSING MODU, 03R65-01, AI01105; ALNTY I PROCESSING MODU, 03R65-01, AI01105
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American