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); Low Test Results (2458)

Patient Problems Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

On (b)(6) 2015, a phone call was received from the end user/patient alleging a variance between the inratio inr result and the physician's point of care (poc) inr result on the testing date of (b)(6) 2015.On (b)(6) 2015: inratio=3.2; physician's poc=3.6 (time between testing was < 2 hours).Historical inratio results: (b)(6) 2015: inratio=3.1, (b)(6) 2015: inratio=4.6.The patient's therapeutic range was 2.5-3.5.Duing this conversation, the patient mentioned that she was hospitalized for a week recently due to a bleeding ulcer.During the hospitalization, she received blood transfusions.The patient was unable to proved the date or or approximate date of the hospitalization.Though requested, no additional information could be provided by the patient.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing history for the lot was performed and the testing met release criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• 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: 5147776
• MDR Text Key: 28149255
• Report Number: 2027969-2015-00843
• 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: Patient
• Type of Report: Followup
• Report Date: 09/21/2015

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: 367839A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• 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
• Treatment: WARFARIN 8MG
• Patient Outcome(s): Hospitalization; Required Intervention