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

Model Number 99008G1

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

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

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio value.Event occurred in (b)(6).Patient's therapeutic range 2.5 (as reported, it is uncertain if this is the low or high end of the patient's therapeutic range) unspecified date: inratio inr 4.2 after receiving a high inratio inr patient suspended his macrumors intake for a few days.A few days later unspecified date: inratio inr 1.9.No reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

Investigation conclusion: in-house testing for the complaint lot was performed and met release criteria.The product performed as expected.Additionally, the manufacturing records for the lot were reviewed and the lot met release specifications.Changes in medication dosages are intended to adjust the measured clotting time.Without a reference result, it is uncertain if the measured inr result is inaccurate.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Corrections: report was updated to add the selection of adverse event to "adverse event or product problem." report was updated to add the selection of other serious (important medical events) to "outcomes attributed to adverse event." describe event or problem was updated to include corrected information.Report was updated to change the selection of malfunction to serious injury for "type of reportable event.".

Event Description

Events occurred in (b)(6).The patient received an inratio inr result of 4.2.The patient initially increased intake of kale and increased marcumar dosage.The patient then suspended the marcumar intake for a few days.The next inr result received was an inratio inr result of 1.9.Patient's therapeutic range= 2.5 as reported; it is uncertain if 2.5 is the low or high end of the patient's therapeutic range.No additional information provided.

• 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: 6254218
• MDR Text Key: 65351579
• Report Number: 2027969-2017-00016
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

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: 99008G1
• Device Lot Number: K396860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• 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: INRATIO MONITOR SERIAL #(B)(4)
• Patient Outcome(s): Other