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

Model Number 100071

Device Problem High Test Results (2457)

Patient Problems Transient Ischemic Attack (2109); Weakness (2145); Ambulation Difficulties (2544)

Event Date 12/12/2014

Event Type  Injury  

Event Description

Patient self tester's wife called with following details: patient's therapeutic range 2-3.On (b)(6) 2014, patient self tester inratio 3.1.On (b)(6) 2014, patient admitted to hospital due to stroke hospital lab inr 1.5.Patient's speech was slurred, unable to walk, general weakness on right side of his body.Patient released from hospital on (b)(6) 2014 to rehab center.Patient in rehab center from (b)(6) 2014.Patient released from rehab on (b)(6) 2014.On (b)(6) 2015, per patient's wife, he is currently doing well.Patient's speech has returned to normal, but his balance is off a little.The only medication patient received while in the hospital was one aspirin.Although additional information was requested, no additional information available.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: the meter associated with the complaint was returned for investigation, however the strips were not returned.Since the strips were not returned for investigation and retain strips for lot# 350587 were not available, lot# 350588 was used for internal investigation purposes to evaluate the performance of the brick lot.Lot# 350588 is identical except for the outer packaging and labeling as lot# 350587.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.The manufacturing records for lot 350587 and 350588 were reviewed.The lots met specifications and no non-conformances were documented.Improper user issues were identified in the complaint.These cannot be ruled out as a possible root cause for the unexpected results.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Investigation/conclusion update: the meter associated with the complaint was returned for investigation, however the strips were not returned.Since the strips were not returned for investigation and retain strips for lot# 350587 were not available, lot# 350588 was used for internal investigation purposes to evaluate the performance of the brick lot.Lot# 350588 is identical except for the outer packaging and labeling as lot# 350587.Upon further investigation, the customer's complaint for discrepant high was confirmed during in-house investigation.Retain strip testing with lot number 350588 on the returned meter failed accuracy criteria.Further investigation into this issue will be pursued under capa-(b)(4).The manufacturing records for lot 350587 and 350588 were reviewed.The lots met specifications and no non-conformances were documented.Improper techniques and user issues were identified in the complaint.These cannot be ruled out as a possible root cause for the unexpected results.Capa-(b)(4) was opened to investigate this issue.

• 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: 4409467
• MDR Text Key: 21541092
• Report Number: 2027969-2015-00018
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2014

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: 100071
• Device Lot Number: 350587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 01/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/20/2015; 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LAMOTRIGINE; INRATIO SERIAL NUMBER (B)(4); MIRTAZAPINE; COUMADIN
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention