MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG URINE CASSETTE 25T; HCG PREGNANCY TEST

Model Number FHC-102-KHS25

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

Patient Problems No Consequences Or Impact To Patient (2199); Pregnancy (3193)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion, investigation pending.

Event Description

Email received from distributor alleging false negative hcg results.Pregnancy was confirmed with sonogram and blood work.(b)(6) old patient; lmp = (b)(6)2015.No additional patient information provided, no adverse patient sequela reported.

Manufacturer Narrative

Investigation conclusion.Customer's observation was not replicated in-house with retention and return devices.Retention and return devices were tested with 25 miu/ml hcg urine control and 3 high level of hcg urine controls (201.8 iu/ml, 203.4 iu/ml and 205.2 iu/ml); all results were hcg positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis and insufficient information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE 25T
• 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: 5166969
• MDR Text Key: 29051262
• Report Number: 2027969-2015-00869
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102-KHS25
• Device Lot Number: HCG4120224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2015
• 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: 21 YR