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

Model Number 100139

Device Problems Shelf Life Exceeded (1567); Low Test Results (2458)

Patient Problem Misdiagnosis (2159)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Caller alleging discrepant inratio value.On (b)(6) 2014, inratio 2.2 lab 8.0.Time between testing 2 hrs.Strips were past expiration date.Pt's therapeutic range 2.0 - 2.5.Pt hospitalized on (b)(6) 2014 for possible pneumonia.Lab upon admission was 8.0.Customer unable to provide treatment or diagnosis.Believes pt was administered vitamin k based on lab result; unsure of dosage.Strips were expired.Pt was discharged on (b)(6) 2014.Lab inr taken on (b)(6) 2014 (day after discharge) was 5.4.Pt was discharged on (b)(6) 2014.Lab inr taken on (b)(6) 2014 (day after discharge) was 5.4.No add'l info available.

Manufacturer Narrative

Investigation pending.

• 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 ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4009627
• MDR Text Key: 4957723
• Report Number: 2027969-2014-00627
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Device Lot Number: 312111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• 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
• Patient Sequence Number: 1
• Treatment: COUMADIN: 6.0 MG P.O. DAILY EXCEPT TUESDAY; HYDROCODONE 5 PER 325 ONE TABLET P.O. -; Q.4H. P.R.N; LEVOTHYROXINE-75 MCG P.O. DAILY; ZANTAC-300 MG P.O. DAILY; LASIX-40 MG 1 P.O. EVERY OTHER DAY; P.O. Q.I.D.; CARBIDOPA/LEVODOPA-5 PER 250 ONE TABLET-; RANEXA-500 MG P.O. B.I.D; ASPIRIN 325 MG P.O. DAILY; DICYCLOMINE-10 MG P.O. Q.I.D; INRATIO MONITOR: SERIAL #(B)(4); PERMARIN VAGINAL CREAM 0.625 MG/GM, 0.5 GM 2/WK; MIRAPEX-2 MG P.O. AT BEDTIME; LANTUS-20 UNITS SUBCUTANEOUS AT BEDTIME; GLIPIZIDE-5 MG P.O. DAILY; LOSARTAN-25 MG 1 P.O. Q.I.D.; PROZAC-20 MG P.O. DAILY