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

Model Number 99008G!

Device Problems Nonstandard Device (1420); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio value.Event occurred in (b)(6).Patient's therapeutic range not provided.Unknown date inratio inr = 2.3.Fourteen (14) days after the inratio inr result, the patient was hospitalized due to an acute gout attack.While in the hospital the following result was obtained: inr via lab = 6.0.Dates of hospitalization and treatment administered is unknown.No additional information provided.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house testing on the reported strip lot met release criteria.The product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Improper techniques and a user issue were identified in the complaint.These could not be ruled out as a cause of 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.The meter associated with the complaint was returned for investigation.In-house testing on the returned meter using retained test strips met accuracy criteria.The customer's complaint was not replicated.The returned meter passed functional and thermistor testing requirements during in-house investigation.The system performed within expectations.A statistical analysis of the impedance curve generated using the customer's reported inratio inr result determined that the curve did not exhibit a weak or abnormal slope.A review of the entire in-house testing history of the lot was performed.In-house testing on the reported strip lot met release criteria.The product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer was identified as having a condition that may impact the performance of the assay, having a user issue, and was using improper technique.Patient sample interference could not be ruled out as a cause for the unexpected result.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: the meter associated with the complaint was returned for investigation.In-house testing on the returned meter using retained test strips met accuracy criteria.The customer's complaint was not replicated.The returned meter passed functional and thermistor testing requirements during in-house investigation.The system performed within expectations.The customer did not provide a date of occurrence which prevented the identification of the discrepant result in the meter memory.Statistical analysis of the impedance curve of a possible inr result was performed and determined that the curve did not exhibit a weak or abnormal slope.It is unknown if this is the actual impedance curve resulting in the reported discrepant result.A review of the entire in-house testing history of the lot was performed.In-house testing on the reported strip lot met release criteria.The product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer was identified as having a condition that may impact the performance of the assay, having a user issue, and was using improper technique.Patient sample interference could not be ruled out as a cause for the unexpected result.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: 5929360
• MDR Text Key: 54528913
• Report Number: 2027969-2016-00604
• 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: consumer,foreign,health profe
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 99008G!
• Device Lot Number: K384108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2016; 01/05/2017; 01/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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-2354-2016- Z-2362-2016
• Patient Sequence Number: 1
• Treatment: ASS; BISOPROLOL; CANDESARTAN; INRATIO MONITOR SERIAL #(B)(4); PANTOPRAZOL; SIMVASTATIN; TRIAMTEREN; UNSPECIFIED ASTHMA MEDICATION