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

Model Number 100139

Device Problems Device Expiration Issue (1216); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

The caller alleged a variance between two (2) inratio inr results.Results are as follows: date: (b)(6) 2015, inratio inr: 0.8 and 2.3.Therapeutic range: 2.0 - 3.0.The testing was performed one after the other.The caller reported that multiple drops of blood was applied to the test strip when the 0.8 result was obtained.Applying more than one drop of blood is considered an improper technique.Additionally, the caller was using testing strips that expired 03/31/2015.Using expired strips is considered off label use.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the customer reported precision issues with inratio inr results during testing.It is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing data was performed.The retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any relevant non-conformances and the lot release specification.Improper technique was identified in the complaint.This could not be ruled out as a possible cause of the unexpected results.In addition, the customer was using expired product for testing.Using expired strips may cause errors and inaccurate test results.This may have contributed to the unexpected results observed by the customer.Based on the information available, there is no indication of a product deficiency and 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: 4682244
• MDR Text Key: 5694384
• Report Number: 2027969-2015-00265
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Model Number: 100139
• Device Lot Number: 334577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• 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
• Treatment: FUROSEMIDE; FENOFIBRATE; ATORVASTATIN; INRATIO MONITOR (B)(4); WARFARIN; CARVEDILOL; LOSARTAN POTASSIUM; ALLOPURINOL; SPIRONOLACTONE; CALCITRIOL