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

Model Number	98814-65
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving a higher reading than a reading from a hcp meter and provided the following results: adc meter: 228 mg/dl vs hcp meter: 53 mg/dl.Customer further reported that on (b)(6) 2018 customer received the reading of 228 mg/dl and took his unspecified regular levemir (insulin detemir) dose.He further noted receiving a reading of 75 mg/dl, but it is unknown when this reading was received.A few hours later, he felt ¿tired and his vision was blurry¿ so he self-presented to his healthcare provider.At the hcp office, a reading of 53 mg/dl was received and he was given two boxes of juice to drink.A subsequent reading of 83 mg/dl was received and no further treatment was required.There was no report of death or permanent injury associated with this event.
Event or Problem Description
Customer reported receiving a higher reading than a reading from a hcp meter and provided the following results: adc meter: 228 mg/dl vs hcp meter: 53 mg/dl.Customer further reported that on (b)(6) 2018 customer received the reading of 228 mg/dl and took his unspecified regular levemir (insulin detemir) dose.He further noted receiving a reading of 75 mg/dl, but it is unknown when this reading was received.A few hours later, he felt ¿tired and his vision was blurry¿ so he self-presented to his healthcare provider.At the hcp office, a reading of 53 mg/dl was received and he was given two boxes of juice to drink.A subsequent reading of 83 mg/dl was received and no further treatment was required.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
(serial number) has been updated based on returned product.Meter (b)(4) has been returned and investigated.Performed visual inspection on returned meter and no issues were observed.Meter powered on with button depression and insertion of retain strips.Control solution testing was performed and results were satisfactory.Returned meter functions were normal.No malfunction or product deficiency was identified.The reported test strips have not been returned for this complaint.Extended investigation was performed and determined that there was no indication that the product did not meet specification.A dhr (device history review) for the precision strips were reviewed and the dhr showed the strips passed all tests prior to release.Retain testing was not performed for precision strips due to strip expiration.The xceed meter was returned and determined to have satisfactory control solution testing results and no other issues were identified.Therefore, no further investigation activities were performed for the xceed meter.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 that 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.

• Brand Name: PRECISION XTRA
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 7814926
• Report Number: 2954323-2018-06373
• Device Sequence Number: 1445033
• Product Code: NBW
• UDI-Device Identifier: 00093815996941
• UDI-Public: 00093815996941
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: 98814-65
• Device Lot Number: 4500169239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 118