MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SURE-VUE SERUM/URINE HCG-STAT; HCG PREGNANCY TEST

Model Number FHC-202-OBC513

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Abdominal Pain (1685); Pregnancy (3193)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated in-house with retention devices and returned patient urine sample.Retention devices were tested (n=29) with three high levels of hcg urine controls (205.2 iu/ml, 208.6 iu/ml, and 216.8 iu/ml) and all results were positive at the 3 minute read time.Customer returned urine sample was tested with retain devices (n=2) and all results were positive at the read time.No false negative results were observed during the investigation.Urinalysis of the returned urine sample showed abnormal results for bilirubin, ketone, blood, protein, and leukocytes.Manufacturing batch record review did not uncover any relevant non-conformance.The customer's false negative results were not replicated during the investigation.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Customer alleging fn hcg on one patient.Customer states test line was not visible.Quantitative serum hcg result: 303,170 miu/ml patient visited the emergency room on (b)(6) 2015 with bilateral abdominal pain for 3 days.Patient had a previous history of pyelonephritis.Medical records state patient had miscarriage one month ago at 4 months along; ultrasound performed on (b)(6) 2015 showed fetal cardiac activity with estimated age of (b)(6).Diagnosis on (b)(6) 2015 was uti and early pregnancy.No additional information provided.

• Brand Name: SURE-VUE SERUM/URINE HCG-STAT
• 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: 5019391
• MDR Text Key: 24784252
• Report Number: 2027969-2015-00607
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-202-OBC513
• Device Lot Number: HCG4120263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 26 YR