MAUDE Adverse Event Report: HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM); HCG PREGNANCY TEST

Model Number FHC-202B-ONC524

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 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation/conclusion: the customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg cutoff urine control and 3 high level of hcg urine controls (201.4 iu/ml, 204.2 iu/ml and 212.2 iu/ml), all results were hcg positive at read time and met quality control specification.There were no false negative results obtained.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined due to insufficient information provided by the customer and without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency and no corrective action is required at this time.

Event Description

The following information was reported on (b)(6) 2016.A customer in (b)(6) alleged a potential false negative hcg result using the hcg one step pregnancy test device (urine/serum) in comparison to an ultrasound which confirmed pregnancy.The testing kits were stored at room temperature and opened directly before the test.The urine was collected "some" minutes before the test procedure and was stored at room temperature.The internal control line was present on the device at the read time.There was no adverse patient sequela.There was no additional information provided.(note: this mdr filing is due to the device being the same or similar as a device available in the united states.).

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5532518
• MDR Text Key: 41424376
• Report Number: 2027969-2016-00193
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: FHC-202B-ONC524
• Device Lot Number: M04KUS02-88
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• 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