MAUDE Adverse Event Report: ALERE SAN DIEGO INC. MCKESSON HCG COMBO; HCG PREGNANCY TEST

Model Number FHC-202-OBW12

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

Customer reported three (3) unconfirmed potential false negative hcg results using the mckesson hcg combo pregnancy test.One (1) patient confirmed a positive pregnancy test on an unspecified home pregnancy test.Two (2) patients had missed their menstrual cycle.Reportedly the urine on all patients was collected in a clean, dry container and tested immediately using three (3) drops of urine.The read time was reported to be three (3) minutes.There was no patient information provided and no quantitative testing performed.There was no adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Customer's complaint was not replicated with retention devices.Retention devices were tested with cutoff hcg control and 3 high level hcg controls.All results were positive at read time.No false negatives were obtained.Manufacturing record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.Product deficiency was not established.This issue will be tracked and trended.

• Brand Name: MCKESSON HCG COMBO
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4292891
• MDR Text Key: 5082616
• Report Number: 2027969-2014-01028
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/30/2014

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 Expiration Date: 07/01/2015
• Device Model Number: FHC-202-OBW12
• Device Lot Number: HCG3090064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/20/2014
• 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