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

Model Number 200432

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Skin Discoloration (2074); Hematuria (2558)

Event Date 09/02/2014

Event Type  Injury  

Event Description

"caller alleged discrepant results compared with the lab.Results as follows:' date; inratio; lab.(b)(6) 2014; 1.8; (b)(6) 2014; ; 'sky high'.Patient self tester's wife was unable to provide the actual inr obtained at the hospital when her husband was admitted.Patient self tester stated that it was 'sky high'.Therapeutic range: 2-3.Patient self tester went to the hospital and was admitted on (b)(6) 2014 due to extreme fatigue and he had been urinating blood for the last 10 days.He also noted bruising on his elbow and lower back.He was given vitamin k injections (unknown type), and 2 bags of frozen platelets while in the hospital.Patient was discharged from the hospital on (b)(6) 2014 with inr=1.1.

Manufacturer Narrative

Customer did not provide a reference value for comparison.Unable to determine the accuracy of the inratio results without this information.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 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 lot met specifications and no non-conformances were documented.No further investigation will be pursued at this time.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

The product 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 and no product deficiencies were observed.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Additional manufacturer narrative: the initial medwatch report indicates that the patient self tester had lab inr that was 'sky high'.Although the patient self tester was unable to provide the exact lab inr result, he stated it was between 12-14 capa (b)(4) was opened to address cases with discrepant low >4 inr.

Manufacturer Narrative

On follow up, the remedial action was checked as a notification but should have indicated it was a recall.Additional information was provided about the meter testing: an impedance curve analysis was performed on the reported results of 1.8 from 09/02/2014, 2.2 from 08/26/2014, and 1.9 from 08/19/2014.Each impedance curve exhibited a weak slope change.Our capa investigation (b)(4) has determined that impedance curves with weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.A notification has been sent to customers to inform them of these patient conditions.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 8588052084
• MDR Report Key: 4142559
• MDR Text Key: 4770992
• Report Number: 2027969-2014-00892
• 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: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/13/2014

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: 200432
• Device Lot Number: 348948
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2014
• Initial Date FDA Received: 09/30/2014
• 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
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: COUMADIN ; MONITOR SN: (B)(4); MONITOR SN: (B)(4); COUMADIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male