MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER-SURE-VUE HCG-STAT SRM/URINE (30T); HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: retention products were tested with hcg quality control cut-off standard (20 miu/ml) and high level hcg clinical urine (212.6 iu/ml, 215.2 iu/ml, 221.9 iu/ml).All devices showed positive results at read time and met quality control specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The reported complaint could not be replicated in-house with retention products.Case details indicate the hcg concentration of the sample was 9 (no units provided).Per the package insert this test has a sensitivity of 20 miu/ml.False negatives may occur when the levels of hcg are below the sensitivity level of the test.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

On (b)(6) 2018, the patient arrived at the facility for birth control counseling and a request to start depo-provera.At 12:12 pm a urine sample was collected and produced a negative hcg result using a fisher-sure-vue hcg-stat serum/urine test.The depo-provera injection was administered based on the fisher-sure-vue hcg-stat serum/urine result.At 4:06 pm, a serum sample was collected and at 5:58 pm indicated the patient was positive for pregnancy: reference range and units is <=4 miu/ml.Result was 9^ and the flag was h.Final result: abnormal.Upon request for clarification, the customer only stated the result was 9 and flagged as high.Per the customer, the patient did not want to be pregnant.Counseling was provided and options given to the patient.Troubleshooting was conducted with the customer.The limitations of the test per the package insert were reviewed regarding testing a sample below the level of detection as well as the negative test interpretation section.

• Brand Name: FISHER-SURE-VUE HCG-STAT SRM/URINE (30T)
• 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: 7858033
• MDR Text Key: 119646386
• Report Number: 2027969-2018-00117
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00613647000571
• UDI-Public: (01)00613647000571(17)200131(10)HCG8010188
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: FHC-A202
• Device Lot Number: HCG8010188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR