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

Model Number 100071

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

Patient Problems Dyspnea (1816); No Consequences Or Impact To Patient (2199)

Event Date 04/28/2015

Event Type  Injury  

Event Description

Patient self tester called from his hospital room alleging discrepant inratio values.(b)(6) 2015 inratio 2.1.(b)(6) 2015 inratio = 7.1 hospital lab = 8.3 exact time between testing unknown, although comparisons were performed on the same day.On (b)(6) 2015 inratio = 4.4 hospital lab = 3.4 exact time between testing unknown, although comparisons were performed on the same day.Patient's therapeutic range 2-3.On (b)(6) 2015 patient self tester was admitted to the hospital for shortness of breath.Patient stated he was administered plasma on (b)(6) 2015 due to his inr results on same day.Patient was not going to be released until his implantable cardioverter defibrillator (icd) was working properly.Date of release from hospital unknown.No additional information provided.

Manufacturer Narrative

Investigation conclusion: investigation pending.

Manufacturer Narrative

Investigation conclusion update: at the time of investigation, retains from lot 358566 were no longer available.As a result, lot 358567 was used for internal investigation purposes.Lot 358567 is made from the same brick lot as 358566 and contains the same raw materials.Lot# 358567 is identical except for the outer packaging and labeling as lot# 358566.The meter 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.The meter and strips continue to meet specification.No product deficiency was found for lot 358566.The release specification is within the calculated confidence interval of the percent flier rate for complaint investigation testing.The impedance curve analysis associated with the result of 4.4 from the reported date of (b)(6) 2015 found the curve appears normal in shape and does not exhibit characteristics of a weak-slope change curve.Although a relevant nc was noted in batch record, it did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.Root cause could not be determined from the information provided by the customer.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 Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4836335
• MDR Text Key: 16885175
• Report Number: 2027969-2015-00405
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2015

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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 358566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2015
• 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
• Treatment: COUMADIN
• Patient Outcome(s): Hospitalization; Required Intervention