MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number 07P51-21

Device Problem False Negative Result (1225)

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false negative alinity i total b-hcg result for one patient sample while running on the alinity i processing module.The following data was provided (/= 25.00 miu/ml is positive): the initial b-hcg result in the morning was < 2.4 miu/ml (negative).The doctor called and questioned the patient¿s negative result.The customer reran the sample on another alinity instrument, and the result was 2000 miu/ml (positive).All the qc was within range.There was no impact to patient management reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from alinity i total b-hcg reagent kit, 07p51-21, longford to alinity i processing module, 03r65-01, irving ia/cc.Mfr report number 3016438761-2024-00059 has been submitted and all further information will be documented under that mfr report number.H3 other text : after further evaluation, the suspect medical device was changed from alinity i total b-hcg reagent kit, 07p51-21, longford to alinity i processing module, 03r65-01, irving ia/cc.Mfr report number 3016438761-2024-00059 has been submitted and all further information will be documented under that mfr report number.

Event Description

The customer reported a false negative alinity i total b-hcg result for one patient sample while running on the alinity i processing module.The following data was provided (/= 25.00 miu/ml is positive): the initial b-hcg result in the morning was < 2.4 miu/ml (negative).The doctor called and questioned the patient¿s negative result.The customer reran the sample on another alinity instrument, and the result was 2000 miu/ml (positive).All the qc was within range.There was no impact to patient management reported.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18369662
• MDR Text Key: 331073510
• Report Number: 3005094123-2023-00382
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P51-21
• Device Lot Number: 55143UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, AI04297; ALNTY I PROCESSING MODU, 03R65-01, AI04297