MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (20MIU/ML) 30T; HCG PREGNANCY TEST

Model Number	92210
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
On (b)(6) 2017, the patient arrived at the emergency department (ed) at 4:57 pm and was admitted for severe right-sided abdominal pain.A urine sample was collected and at 7:04 pm the alere hcg cassette produced a negative hcg result.A transvaginal pelvis ultrasound was conducted at 8:21 pm and showed a possible corpus luteal cyst in the right side.The ultrasound also showed a possible very early intrauterine pregnancy.As a negative result was received using the alere hcg cassette, an abdomen pelvis with contrast ct was conducted to evaluate the patient for appendicitis given continued pain.At 9:01 pm, the ct scan result was unremarkable.At 10:17 pm, an hcg test using the siemens centaur cp was ordered on a sample collected earlier.At 11:05 pm, the siemens centaur cp produced a positive hcg result of 1312 miu/ml.The customer also mentioned receiving 4-5 false negative results on multiple patients using the alere hcg cassette but could not provide any additional information.
Additional Manufacturer Narrative
Investigation conclusion: the customer's observation was not replicated in-house with retention and return products of the reported lot.Retention and returned products were tested with qc cut-off hcg standards.All devices showed positive results at read time 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 as 1312 miu/ml.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.Corrected data: (initial reporter also sent report to fda) corrected to yes.

• Brand Name: ALERE HCG CASSETTE (20MIU/ML) 30T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7097966
• Report Number: 2027969-2017-00181
• Device Sequence Number: 903514
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)190331(10)HCG7040129
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 92210
• Device Lot Number: HCG7040129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR