MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URINE CASSETTE 5001 25T; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with qc cut-off standard (20miu/ml hcg urine) in 29 replicates.All results gave a correct positive results at 3 minutes and met qc specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The serum quant for the patient was reported at 31miu/ml hcg concentration.A dilute urine sample may make the hcg quant level much less than the serum levels which may lead to false results.Some patients may test negative early in pregnancy if the urine hcg is below the cut-off of 20 miu/ml.It is recommended that if pregnancy is suspected, a first morning urine specimen should be collected 48 hours later and tested.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The patient's last menstrual period was (b)(6) 2018.On (b)(6) 2018, the patient went to the facility to have an iud inserted.At approximately 11:00am, a urine sample was collected and at 11:10am a consult hcg urine cassette produced a negative hcg result at 3 minutes.However, at 5 minutes, a positive result was observed.(per corresponding package insert, results should be read between 3 and 5 minutes only.) the result was interpreted as "undetermined." the patient opted to continue with the iud placement given the consult hcg urine cassette result.At 12:30pm, a blood sample was collected and sent to (b)(6).A serum beta hcg quantitative result of 31 miu/ml was received some time after the iud insertion.On (b)(6) 2018, the patient returned to facility and a fresh urine sample was collected.A second consult hcg urine cassette produced a negative hcg result at 3 minutes and a positive result after 5 minutes.The result was interpreted as positive.The iud was subsequently removed.On (b)(6) 2018, a new blood sample was collected and produced a serum beta hcg quantitative result of102 miu/ml.On (b)(6) 2018, the patient missed an obstetrics (ob) appointment.On (b)(6) 2018, the nurse called the patient to attempt to reschedule the appointment.The patient informed the nurse that she had experienced bleeding and a possible miscarriage.The date of these events was not provided.The patient was rescheduled for an evaluation appointment on (b)(6) 2018 and arrived at facility but left without being seen.On (b)(6) 2018, a blood sample was drawn and produced a serum beta hcg quantitative result of <1 miu/ml.The patient was provided with information regarding the "undetermined" result and elected to continue with the iud placement before receiving a confirmatory result.There is insufficient information to suggest the consult hcg urine cassette caused or contributed to the decision to proceed with the insertion of the iud or the subsequent miscarriage.Additionally, a positive hcg result developed within the appropriate read time of the device prior to iud insertion.This event is being reported due to the negative result within the appropriate read time occurring on (b)(6) 2018.

• Brand Name: CONSULT HCG URINE CASSETTE 5001 25T
• Type of Device: HCG 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: 7538950
• MDR Text Key: 109116091
• Report Number: 2027969-2018-00057
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)190831(10)HCG7090067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A102
• Device Lot Number: HCG7090067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 65