MAUDE Adverse Event Report: ALERE SAN DIEGO, INC HENRY SCHEIN HCG COMBO CASSETTE; PREGNANCY TEST

Model Number FHC-202

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere san diego.Alere san diego updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere san diego (reference (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: retention devices for each of the reported lots were tested with clinical negative urine samples and qc cutoff standards (25 miu/ml).Results were read at 3 minutes.All devices tested with the clinical urine samples yielded expected negative results.All devices tested with the qc cut off standard yielded expected positive results.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Retention devices performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.This test provides a presumptive diagnosis for pregnancy.There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.Please refer to the limitations and interfering substances section of the package insert.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.Customer to monitor.Devices not returned.

Event Description

(b)(6) 2018: patient presented to the facility for an unspecified reason.The same patient urine sample was tested 3x on three different lot numbers yesterday and received conflicting results: first test in ob/gyn department: ln hcg8050157-negative at 3min.Second test in stat department: ln hcg8010037- positive at 3 min 20 seconds.Third test in customer's lab: ln hcg8050175- negative at 3 minutes, positive at 3min 20 seconds.No confirmatory testing was performed.No treatment was provided or delayed based on the conflicting results.Although further information was requested, no further information able to be provided by the customer.Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi)-no deviations noted.Technical services specialist informed customer per the pi: this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.The read time for urine samples is 3 minutes.

• Brand Name: HENRY SCHEIN HCG COMBO CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9131296
• MDR Text Key: 160503261
• Report Number: 2027969-2019-00538
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024123
• UDI-Public: (01)10304040024123(17)200430(10)HCG8050157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• 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
• Report Date: 09/27/2019

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: 04/30/2020
• Device Model Number: FHC-202
• Device Catalogue Number: 9004075
• Device Lot Number: HCG8050157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 09/27/2019
• 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
• Patient Outcome(s): Required Intervention