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 Problem Myocardial Infarction (1969)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Event occurred in (b)(6).Report received of discrepant inratio values.Patient's therapeutic range 2-3.Preferred inr is 2.5 the following information was initially reported.On (b)(6) 2016 inratio inr = 3.0: laboratory inr = 1.9.It was reported patient was hospitalized for a minor heart attack from micro-clots.Date and details of hospitalization have not been provided.Upon further investigation, the following data was obtained.Unspecified date: inratio inr = 3.1 on (b)(6) 2016 inratio inr = 3.0; warfarin decreased from 5 mg to 4 mg.On (b)(6) 2016 inratio inr = 3.1; warfarin decreased from 5 mg to 4 mg (it is unknown when warfarin was increased from 4 mg to 5 mg).On (b)(6) 2016 laboratory inr = 1.4 patient hospitalized.Treatment included aspirin, heparin and warfarin for blood thinning.Hospital details unknown.On (b)(6) 2016 inratio inr = 2.8; laboratory inr = 1.6 warfarin 7 mg.On (b)(6) 2016 inratio inr = 2.8; laboratory inr = 1.7 warfarin 7 mg.Multiple attempts have been made to clarify and to obtain additional information; however, no additional information has been provided.It was reported after (b)(6) 2016 there were no further comparisons.

Manufacturer Narrative

Investigation conclusion: the meter associated with the complaint was returned for investigation.Functional and thermistor testing were performed on the returned meter with passing results.The customer's complaint was not confirmed during in-house testing.Retain strips tested on the returned meter met accuracy criteria.A review of the batch records for lot 382043 uncovered a relevant nc.However, this did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.Impedance curve analysis was not performed because the customer's reported inr results could not be identified in the meter memory.Although an improper technique was identified in the complaint, a root cause could not be determine from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Correction: originally listed model # as hs99007g1.Correction: model # 100071.Investigation conclusion update: the meter associated with the complaint was returned for investigation.The customer's complaint was not confirmed during in-house testing.Return and retain strips tested on the returned meter met accuracy criteria.Functional and thermistor testing were performed on the returned meter with passing results.A review of the batch records for lot 382043 uncovered a relevant non-conformance.However, this did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.Impedance curve analysis was not performed because the customer's reported inr results could not be identified in the meter memory.Although an improper technique was identified in the complaint, a root cause could not be determine from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• 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: 5509303
• MDR Text Key: 40640137
• Report Number: 2027969-2016-00174
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2016

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: 100071
• Device Lot Number: 382043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2016; 07/01/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention