MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. PRECISION XTRA; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 98814-65

Device Problem Calibration Problem (2890)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The actual date when the medical event occurred is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller, calling on behalf of a customer, reported the customer was having difficulty calibrating his adc blood glucose meter.It was further reported that on an unspecified date/time, because of this issue, he was unable to check his ketones.Customer was taken to the hospital where he received unspecified treatment for ¿dka¿.No further information was provided as the caller declined to continue troubleshooting.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The useful life of precision xceed meter (precision xtra) is 5 years.As the manufacturing date of this product is in november 2009, it has been in distribution beyond its useful life as of the case awareness date of september 06.2017.Since the product exceeded its useful life, it is determined to have met specification when the product was released and through its lifespan.Therefore, no further investigation activities are required for the precision xceed meter.A dhr (device history review) for the precision ketone test strips was reviewed and showed the ketone test strips passed all tests before release.As the strip lot associated with this case was past its expiry date of april 30, 2018 at the time of investigation, retain testing was not performed.No further activities related to calibrators will be performed as the reported ketone test strips do not require a calibrator.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.This also serves as a correction report.Was inadvertently missing from the initial mdr 30 day report.Has been updated.

Event Description

A caller, calling on behalf of a customer, reported the customer was having difficulty calibrating his adc blood glucose meter.It was further reported that on an unspecified date/time, because of this issue, he was unable to check his ketones.Customer was taken to the hospital where he received unspecified treatment for ¿dka¿.No further information was provided as the caller declined to continue troubleshooting.There was no report of death or permanent injury associated with this event.

• Brand Name: PRECISION XTRA
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 6905966
• MDR Text Key: 87839999
• Report Number: 2954323-2017-06717
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 98814-65
• Device Lot Number: 75001G56
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention