MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ICON 25 HCG (COMBO CASSETTE); HCG PREGNANCY

Model Number FHC202

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

Caller alleged false negative hcg results for one pt.Results as follows: customer rec'd a false negative hcg result using first morning urine from a pt who was (b)(6) pregnant.Expiration date: 09/2015.No pt info was provided.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with high level hcg positive urine controls.All results were positive at read time.No false negatives were obtained.Mfg batch record review did not uncover any abnormalities.Root cause could not be determined w/o pt specimen in-house analysis.Based on the info, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subject to tracking and trending.

• Brand Name: ICON 25 HCG (COMBO CASSETTE)
• Type of Device: HCG PREGNANCY
• 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: 3871502
• MDR Text Key: 20457568
• Report Number: 2027969-2014-00341
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC202
• Device Lot Number: HCG310029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2014
• 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