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

Model Number 98814-65

Device Problems Device Displays Incorrect Message (2591); Calibration Problem (2890)

Patient Problems Weakness (2145); Dizziness (2194); Loss of consciousness (2418)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

The customer¿s products have been requested for an investigation.A follow-up report will be filed once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller (customer¿s daughter) reported ¿they were having trouble¿ with her mother¿s adc blood glucose meter.The caller reported they received an error-6 message upon test strip insertion and sample application.It was also noted during troubleshooting that the meter had a calibration issue.As a result of these issues, the customer was unable to test her blood glucose.Caller reported that sometime before 9:30 am on (b)(6)2017 her mother was feeling dizzy, weak and unable to move.The customer also experienced a loss of consciousness.The customer was rushed to a hospital, where she was treated with metformin, glyburide and warfarin (a non-diabetic medication).The caller stated she did not know what her mother¿s diagnosis was as she ¿did not know exactly what happened after they brought her mother to the hospital¿.The caller declined to provide additional information or complete troubleshooting.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

This serves as a correction report.(unique identifier (udi) # ) was incorrectly documented as not applicable in the initial mdr 30 day report.

Event Description

A caller (customer¿s daughter) reported ¿they were having trouble¿ with her mother¿s adc blood glucose meter.The caller reported they received an error-6 message upon test strip insertion and sample application.It was also noted during troubleshooting that the meter had a calibration issue.As a result of these issues, the customer was unable to test her blood glucose.Caller reported that sometime before 9:30 am on (b)(6) 2017 her mother was feeling dizzy, weak and unable to move.The customer also experienced a loss of consciousness.The customer was rushed to a hospital, where she was treated with metformin, glyburide and warfarin (a non-diabetic medication).The caller stated she did not know what her mother¿s diagnosis was as she ¿did not know exactly what happened after they brought her mother to the hospital¿.The caller declined to provide additional information or complete troubleshooting.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.The complaint was investigated and determined that there was no indication that the product did not meet specification.All error codes for the reported complaint and precision xceed meters correspond to meter related errors, calibrator related errors, or strip expiry errors.The reported strip lot 65321 was past its expiration date of september 30, 2016 at the time of the complaint (b)(6)2017; therefore, no investigation activities were performed for this lot.As the issue is related to the meter, no investigation activities relating to strips, such as dhr reviews, retain testing, clinical or stability reviews, were performed.The useful life of xceed meter is 5 years.As the manufacturing date of this product is before 2010, it has been in distribution beyond its useful life as of the case awareness date of (b)(6)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.If the product is returned, the case will be re-opened and a physical investigation will be performed.- attachment: [attachments.Zip].

Event Description

A caller (customer¿s daughter) reported ¿they were having trouble¿ with her mother¿s adc blood glucose meter.The caller reported they received an error-6 message upon test strip insertion and sample application.It was also noted during troubleshooting that the meter had a calibration issue.As a result of these issues, the customer was unable to test her blood glucose.Caller reported that sometime before (b)(6)am on (b)(6)2017 her mother was feeling dizzy, weak and unable to move.The customer also experienced a loss of consciousness.The customer was rushed to a hospital, where she was treated with metformin, glyburide and warfarin (a non-diabetic medication).The caller stated she did not know what her mother¿s diagnosis was as she ¿did not know exactly what happened after they brought her mother to the hospital¿.The caller declined to provide additional information or complete 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: 6314647
• MDR Text Key: 66912503
• Report Number: 2954323-2017-01173
• 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,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 98814-65
• Device Catalogue Number: 98814-65
• Device Lot Number: 65321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2009
• 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
• Patient Age: 86 YR
• Patient Weight: 82