MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG DIPSTICK TEST; PREGNANCY TEST

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting was performed with the customer.Reviewed limitations of test 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.Reviewed hcg product information notice (pin) with customer which discusses the intended use and limitations of the test.Investigation pending.

Event Description

The patient tested herself on an at home urine pregnancy test on (b)(6) 2018-all three at home tests were negative.Another home urine pregnancy test was done on (b)(6) 2018 and was positive.The type/brand of home urine pregnancy test unknown.On (b)(6) 2018: due to the positive home test, the patient came into the facility to confirm her pregnancy.A new urine sample was collected at the facility and tested twice on the mckesson consult urine dipstick-both tests resulted in negative.The patient was insistent she was pregnant due to the positive home pregnancy test results.Her blood was collected and sent for confirmatory testing on (b)(6) 2018.(b)(6) 2018: the results became available.Beta quant=51 miu/ml.Based off serum results, the facility is determining patient to be pregnant.There was no treatment provided or withheld from the questionable negative mckesson consult urine dipstick result.The patient was referred to the ob department.

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention and returned product from the reported lot number.Retention and returned devices were tested with qc cutoff standards (25 miu/ml).Results were read at 3 minutes.All devices yielded expected positive results and met qc specifications.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.A root cause could not be determined from the available information, as both retention and returned product performed as expected during in-house testing.False negative results may occur when the levels of hcg are below the sensitivity level of the test.Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still expected, a first morning urine specimen should be collected 48 hours later and tested.

• Brand Name: CONSULT HCG DIPSTICK TEST
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 8191933
• MDR Text Key: 132063222
• Report Number: 2027969-2018-00168
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202751
• UDI-Public: (01)20612479202751(17)200630(10)HCG8070090
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: FHC-101
• Device Lot Number: HCG8070090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 02/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR