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

Model Number FHC-202

Device Problem False Negative Result (1225)

Patient Problems Pain (1994); Radiation Exposure, Unintended (3164)

Event Date 01/06/2014

Event Type  Injury  

Event Description

Caller alleged false negative hcg results.Results as follows: patient presented to the e.R.With abdominal pain between 1:00 and 2:00 pm.Patient's urine was tested using the icon 25 hcg test with negative results.A cat scan was done on the patient showing the presence of a fetus equivalent to (b)(6) old.Specific gravity of patient's urine = > 1.030.Patient's urine was re-tested with negative (-) results.Control lines on tests were good.Patient's serum and urine were quantitated.Serum = 46,000 miu/ml; quantitative results were not provided.Patient was told to follow up with her physician and given information on genetic counseling due to her exposure to radiation with the cat scan.Unknown if any treatment was given to the patient after discovery of her pregnancy.It is not known if the patient was asked if she was pregnant before the cat scan was performed, or if the patient knew she was pregnant.No patient information was provided.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with 3 different high level hcg urine controls, and 3 samples of clinical positive urine.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 from the information provided.Based on the information available, there is no indication of a product deficiency.Corrective action is not 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 king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3612021
• MDR Text Key: 4093924
• Report Number: 2027969-2014-00066
• 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: 01/13/2014

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
• Device Operator: Health Professional
• Device Model Number: FHC-202
• Device Lot Number: HCG3040235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 01/29/2014
• 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
• Patient Outcome(s): Other