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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problems Dizziness (2194); Anxiety (2328)

Event Date 09/16/2021

Event Type  Injury  

Event Description

01 dec 2021 - the competent authority for (b)(6) emailed to provide an incident report- (b)(4) which details a false negative result that occurred with alere hcg test kit lot number (l0111842) on the (b)(6) 2021.The lot number provided is not an abon lot number.The customer stated that the product was manufactured by abon therefore, the abon site will investigate the issue reported.The report stated that the patient was attending a consultation for nodular scarring acne on (b)(6) 2021 and the patient was prescribed isotretinoin.At a review consultation on the (b)(6) 2021 the patient informed that they had been detected to be pregnant(8 weeks gestation).The patient stated that she felt dizzy and tired a few days earlier.On the day of the onsite visit the patient was on her second day of a pregnancy termination drug (drug not specified).The customer noted that the patient was in a sound state of mind but very anxious.The customer stated that isotretinoin is prescribed monthly to patients and is only commenced after ensuring adequate contraception and a negative pregnancy test.Pregnancy test was carried out by nursing staff onsite on the (b)(6) 2021 which gave a negative result.The customer stated that the patient went through heavy emotional trauma due to the incident.The acne treatment was suspended immediately.Due to this incident, the patients management of acne is currently interrupted until she recovers.The customer did not provide details of the pregnancy termination drug or the adequate contraception referenced above.Although requested, the complaint product lot number was not provided and no further details have been provided.

Manufacturer Narrative

The alleged false negative result occurred with alere hcg cassette 25 miu/ml on (b)(6)2021.The alleged false negative result occurred on fhc-102 product when testing the patient sample.The customer reported that the patient was attending a consultation for nodular scarring acne.At the previous appointment on (b)(6) 2021 the patient was prescribed isotretinoin.A pregnancy test was carried out by nursing staff on site on (b)(6) 2021 which gave a negative result.At the review consultation on (b)(6) 2021 the patient informed that they had been detected to be pregnant ((b)(6)).The acne treatment was suspended immediately.The complaint product lot number was not provided.As complaint product lot number was not provided , 3 retained product lots were randomly collected within the expiration date which was shipped to the (b)(6) market for investigation as the country of occurence is the (b)(6): hcg0032013, hcg0082071, hcg1052060.No further information has been provided by the customer, due diligence performed.The batch record of lots# hcg0032013, hcg0082071, hcg1052060 were reviewed, the quality control (qc) release data met release specification.No deviation was observed in the finished product, semi-finished strip as well the strip components manufacturing process.The working concentration used in the key components met manufacturing criteria.The retain product investigation was performed on 3 retain lots.Visual inspection was performed for the packaging and devices; 10 retained devices were intact for each lot.For lots:# hcg0032013, hcg0082071, hcg1052060 10 retained devices were tested with qc positive samples in 1 replicate per urine for each lot; results were read at 3 minutes.All retained devices showed expected positive results.False negative results were not observed.Therefore, the product met qc release specification.Information regarding product storage and testing technique is not provided therefore, a probable cause was not identified.In conclusion, from the investigation completed the customer reported issue was not replicated and no product deficiency was identified during this investigation.

Manufacturer Narrative

Correction to b4 'date of this report': incorrect date of report provided on initial mdr.Please note the initial mdr was submitted on 20dec2021.

• Brand Name: ALERE HCG CASSETTE
• Type of Device: PREGNANCT 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: 13043181
• MDR Text Key: 284382205
• Report Number: 3005641941-2021-00019
• 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,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ISOTRETINOIN
• Patient Outcome(s): Other
• Patient Sex: Female