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

Model Number 100139J

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

This event occurred in (b)(6).The customer reported a variance between the inratio inr results on a patient using a syringe and venous blood sample.On (b)(6) 2015, the inratio inr was 5.1 and at the hospital the inr was 1.8.On (b)(6) 2015, the inratio inr was 7.3 and at the clinical laboratory the inr was 1.77.The patient's therapeutic range and time between testing was unknown.The available information is limited and no additional information is able to be obtained.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, in-house retain testing was performed.In-house testing on retained strip lot 368479 meets criteria.A review of the entire in-house testing history for lot 368479 was also performed.In-house testing for lot 368479 meets expectations.A review of the manufacturing records for lot 368479 did not uncover any non-conformances.The lot meets release specification.Root cause cannot be determined from the 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: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5157525
• MDR Text Key: 28917363
• Report Number: 2027969-2015-00852
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139J
• Device Lot Number: 368479
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2015
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• 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