MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO 2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 55128A

Device Problems No Display/Image (1183); Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

The meter was returned for investigation.When powered up the customer's issue was observed.The led screen incorrectly displayed the prothrombin time (pt).Product support readjusted the display relieving any extra pressure and allowed the lcd segments to function as expected.Further inspection of returned meter did not reveal any moisture nor sample contamination.The inratio2 monitor display issue is being thoroughly investigated by the vendor hti.When this investigation is finalized, a follow-up medwatch report will be submitted with any relevant information.

Event Description

Customer reported that the led screen on their inratio monitor had incorrectly displayed numbers/letters as if some lines were no longer functioning.The center led readout was not working and did not form numbers correctly.The customer said they noticed the issue before calling and were unable to test because they could not get past the strip code verification due to the screen display issue.Customer was unable to test or get results.

Manufacturer Narrative

Updated conclusion: the meter associated with the case was returned for investigation.The customer's complaint of a display issue was replicated during in-house investigation.Readjusting the display relieved any extra pressure and allowed the lcd segments to display properly.Visual investigation did not uncover contamination on the device.Issues of missing segments on inratio 2 meter display was investigated and as a result, a corrective action was initiated.This instrument was manufactured prior to the implementation of the corrective actions that were implemented.The last sentence on the initial medwatch report stated: 'when the investigation is finalized, a follow-up medwatch report will be submitted with any relevant information.' this sentence should have read "hti initiated a supplier corrective action to address the issue.".

• Brand Name: INRATIO 2 PT MONITORING SYSTEM
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4932679
• MDR Text Key: 22661968
• Report Number: 2027969-2015-00531
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/01/2015

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: Health Professional
• Device Model Number: 55128A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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