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  

Event Description

On (b)(6) 2022 customer reported that they obtained four false negative results when using alere hcg cassette, product code: 4551149016, lot: hcg2052076 and hcg2052068.Date of occurence unknown.This mdr is raised for lot: hcg2052068.Although requested, no further information was provided.Due to insufficient information provided unable to identify any misuse or deviation against the package insert.

Manufacturer Narrative

Investigation results: review of batch history record and deviation history confirmed no relevant non-conformance's 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 insufficient 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.It was reported that the customer experienced multiple false-negative results with 2 different lots.This mdr is related to mdr 3005641941-2022-00003.

• 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: 15737042
• MDR Text Key: 307196162
• Report Number: 3005641941-2022-00004
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: FHC-102
• Device Lot Number: HCG2052068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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 Sex: Female