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

Model Number 100139

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458); Appropriate Term/Code Not Available (3191)

Patient Problems Coagulation Disorder (1779); No Code Available (3191)

Event Date 05/19/2015

Event Type  Injury  

Event Description

The customer called in questioning why they had not received the medical device correction notification that they had found on the alere website, while reviewing the return policy.The customer alleged variances between multiple inratio inr results and laboratory inr results on multiple patients with some patients admitted to the hospital.The specific dates and results were not available.There was only one (1) patient result provided; however, the date was unknown.Additionally, the specific lot number and monitor serial number could not be provided.The customer could not verify which of these lot numbers (357496 or 367327a) had the variance.Results are as follows: date: unknown, inratio inr: 3.1, laboratory inr: 12.6.Therapeutic range: unknown.The patient was hospitalized and outcome/treatment could not be provided by the customer.Though requested, there was no additional information provided.

Manufacturer Narrative

Estimated as the date the call was received, (b)(6) 2015, since the customer could not provide the actual date of the event and the call was received on (b)(6) 2015.The pt/inr test strips lot # 357496 referenced, is be reported under a separate manufacturer report number 2027969-2015-00406.Investigation pending.

Manufacturer Narrative

Investigation/conclusion: the products associated with the complaint were returned for investigation.A review of the monitor memories could not determine if either monitor was used to obtain the customer's reported result.The returned monitor memories were downloaded and reviewed.The reported strip lot #367327a has strip code# t87xk.The monitor's memory did not contain the reported strip code#t87xk.Should additional case information be provided in the future, further investigation with the appropriate monitor will be pursued.A review of in-house testing of lot 367327a was performed.The retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and the lot met release specifications.The root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Further investigation was performed under capa-(b)(4).

• 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 (Section G): 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: 4844433
• MDR Text Key: 20154982
• Report Number: 2027969-2015-00407
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• 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: 367327A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• 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: INRATIO PT/INR TEST STRIPS LOT # 357496; INRATIO MONITOR SN (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention