MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD ALERE HCG CASSETTE; PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Investigation results: review of batch history record and deviation history confimed no relevant non-conformances and deviations and the quality control (qc) release data met qc specification.Customer's observation was not replicated in-house with retention products.Retention devices were tested in-house clinical.All results were negative at 3 minutes read time and met qc specification.All retained devices showed expected positive results.False negative results were not observed.Manufacturing batch record review did not identify any abnormalities.Due to insifficient information provided and no patient specimen returned for analysis.Root cause could not be determined.In conclusion, customer reported issue was not replicated.No product deficiency was identified during this investigation.This complaint will be tracked and trended.

Event Description

On the (b)(6) 2022 customer reported two false negative results on the same patient when using alere hcg cassette product code 4551149016, lot number hcg1122029.Customer explained that the patient was 4 weeks pregnant and obtained a positive blood result for hcg and tested positive with the smae product at another medical centre.Review of the information provided did not identify any evidence of misuse.No deviations were noted regarding product and specimen storage, handling, or testing technique.

• Brand Name: ALERE HCG CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ABON BIOPHARM (HANGZHOU) CO., LTD; no.198 12th street east; economic tech development area; hangzhou, zhejiang 31001 8; CH 310018
• Manufacturer Contact: joe shen ; no.198 12th street east; economic tech development area; hangzhou, zhejiang 31001-8 ; CH 310018
• MDR Report Key: 15736068
• MDR Text Key: 307584373
• Report Number: 3005641941-2022-00005
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: FHC-102
• Device Lot Number: HCG1122029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female