MAUDE Adverse Event Report: ALERE MCKESSON HCG DIPSTICK; HCG PREGNANCY TEST

Model Number FHC-111-0BN01

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

Patient Problem Mitral Insufficiency (1963)

Event Date 06/17/2014

Event Type  Injury  

Event Description

Customer alleged potential false negative urine hcg results using the mckesson hcg dipstick.The following information was reported: (b)(6) 2014: last menstrual period, heavy flow; (b)(6) 2014: negative laboratory serum hcg test; (b)(6) 2014: heavy flow; (b)(6) 2014: negative urine mckesson hcg dipstick.Based on the negative urine hcg, patient underwent a saline sonogram.The patient was diagnosed as pregnant based on the quantitative laboratory hcg of 307.Customer retested the sample, two (2) hours later using a new kit and received a positive result.Time the sample was collected? < 15 minutes, not the first void.Sample stored and tested at four (4) minutes.Internal control line present on device.External controls ran when kit was received it is good.This test was the last one from the kit and the kit and therefore unable to rerun controls or sample.Additional information received on (b)(4) 2014 as follows: the patient is in the process of miscarriage.There has been an abnormal rise of hcg since the initial positive test and a transvaginal ultrasound showed a small sac.The patient has also experienced bleeding and a blood test on (b)(6) 2014, revealed declining hcg levels.A dilation and curettage (d&c) may still be necessary, but the physician is waiting to see.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with hcg 25 miu/ml cutoff urine control and 100 miu/ml hcg urine control, 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 without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subjected to tracking and trending.

• Brand Name: MCKESSON HCG DIPSTICK
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3946311
• MDR Text Key: 4531769
• Report Number: 2027969-2014-00644
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2014

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 Expiration Date: 09/01/2015
• Device Model Number: FHC-111-0BN01
• Device Lot Number: HCG3110005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/09/2014
• 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
• Patient Age: 27 YR