MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG COMBO DEVICE SP BRAND RAPID TEST; HCG PREGNANCY TEST

Model Number FHC-A202-OBW515

Device Problem False Negative Result (1225)

Patient Problems Hemorrhage/Bleeding (1888); Urinary Tract Infection (2120)

Event Date 05/12/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml hcg urine cutoff control and 100 miu/ml hcg control, all results were positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Received an email from distributor alleging false negative hcg: course of events: home pregnancy test (b)(6) 2015 was positive.((b)(6) 2015).Bleeding for several days, active bleed upon presentation to the emergency department (b)(6) 2015.Abdominal ultrascan showed no definitive intrauterine pregnancy, not ectopic.No meds on file.(b)(6) 2015 4:11pm, urine rapid=negative, beta hcg=163 (kit lot number hcg4080261) with "poc urine preg negative.But then repeat with faintly positive results." patient represented to the emergency department on (b)(6) 2015 for chlamydia treatment.Vaginal bleeding had stopped.(b)(6) 2015 2:35pm, urine rapid=negative (accurate lot number not provided), beta hcg=254.Chart = "no sonographic evidence of intrauterine gestation sac.Could be ectopic." serum beta hcg quant = 254 miu/ml.Diagnosis = "vaginal bleeding, pregnancy first trimester with uti." no additional information received.

• Brand Name: HCG COMBO DEVICE SP BRAND RAPID TEST
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ABON BIOPHARM (HANGOU) CO. LTD.; #198 12th street east; hangzhou economic & technologi; hangzhou, zhejiang zhejiang 31001 8; CH 310018
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4974715
• MDR Text Key: 23710231
• Report Number: 2027969-2015-00566
• Device Sequence Number: 1
• Product Code: JHI
• 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: health professional
• Reporter Occupation: Other
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202-OBW515
• Device Lot Number: HCG4080261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• 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