MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problems Shelf Life Exceeded (1567); Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant inratio results.Results as follows: inratio: 6.5; lab :2.7; time between test: 10 minutes.Therapeutic range: 2-3.Using expired range: 2-3.Using expired strips.Caller reports that the meter was not in the correct mode when finger stick was performed, and "milking" of the finger occurred.

Manufacturer Narrative

Investigation pending device return.

Manufacturer Narrative

The product associated with the complaint was returned for investigation.The complaint was not confirmed during in-house investigation.Investigation of the returned meter using retain strips did not uncover any deficiencies.During thermometer sensing test, the heater plate thermistors failed to meet specification.Because the heater plate thermistors failed to meet spec, 'fi-14-036' was opened.Further investigation will be pursued under fi-11-036.Improper techniques and improper use of the meter were identified in the complaint.These cannot be ruled out as a possible root cause for the unexpected results.Additionally, the customer utilized expired inratio strips during testing.The customer's use of expired products cannot be ruled out as a possible root cause for the unexpected results.The manufacturing records for the lot were reviewed.The lot met specs and no non-conformances were documented.

Manufacturer Narrative

Statistical analysis of testing performed as part of an extended complaint failure investigation reference (b)(4) found there to be no significant difference in inr values between returned meters that failed the heating specification and meters that passed the heating specification.No further investigation will be pursued.Corrective action is not required at this time.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• 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: 3949170
• MDR Text Key: 16308054
• Report Number: 2027969-2014-00397
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 303231
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR, SERIAL #(B)(4); ORAL ANTICOAGULANT; ORAL ANTICOAGULANT; INRATIO MONITOR, SERIAL #(B)(4)
• Patient Sex: Female