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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problem Test Result (2695)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

Caller alleged discrepant inratio results.Results as follows: inratio: 3.0, lab: 6.5.Tests were performed within 1 hour of each other.Therapeutic range: 2.5-3.5.Though caller states the lab inr was 6.5, she does indicate that her husband has no indications/ clinical symptoms of a high inr that would usually be present if his inr was high.There was no unexpected bleeding or bruising and she says this makes her critical of the lab value.No intervention or treatment was given.

Manufacturer Narrative

It is indicated that product is not returning for evaluation.Therefore, investigation of the complaint to determine root cause cannot be completed.Root cause could not be determined from the information provided by the customer.Since the product associated with the complaint was not returned, a review of in-house testing was performed.Retain strip testing results met both accuracy and repeatability criteria.The products performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed.The non-conformances associated with this lot were not relevant to the initial complaint and does not affect product performance.Root cause could not be determined from the information provided by the customer.Corrective action is not required at this time as product deficiency was not established.

• 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 CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4739966
• MDR Text Key: 5827367
• Report Number: 2027969-2015-00314
• 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: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• 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: PRAVASTATIN 10MG, OXYBUTYNIN (PRN),; POTASSIUM 10MEQ DAILY, MULTIVITAMIN,; MEDICATIONS: WARFARIN 4.5 MG/DAY,; (1 TAB AM, 0.5 TAB PM), FUROSEMIDE 20MG (1.5 TAB),; HYDROCHOLORTHIAZIDE 25MG 2 TABS/DAY), SOTOLOL 80MG; INRATIO MONITOR SERIAL #(B)(4); GABAPENTIN 300MG (PRN)