MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCUTREND CHOLESTEROL; CHOLESTEROL (TOTAL) TEST SYSTEM

Catalog Number 11418262171

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).Occupation: occupation ni equals lay user / patient.

Event Description

The initial reporter complained of questionable results from an accutrend plus meter serial number (b)(4).At 6:19 am the result from the meter was 5.30 mmol/l.At 6:26 am the result from the meter was 6.93 mmol/l.At 6:36 am the result from the meter was 4.29 mmol/l.At 6:41 am the result from the meter was 6.46 mmol/l.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer stated that they perform the testing first thing in the morning after fasting.The customer's meter and test strip have been requested for return.

Manufacturer Narrative

The customer's meter and strips were returned for investigation.The returned product was measured in comparison to a retention meter and master lot strips.Testing results (qc range: 151 - 193 mg/dl): qc 1: 180 mg/dl, qc 2: 173 mg/dl, qc 3: 176 mg/dl.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.Customer samples cholesterol lot 349024-02 and retention samples cholesterol lot 349024-02 were measured with controls level low /high lot 403614-01 on customer accutrend plus devices and reference devices.

• Brand Name: ACCUTREND CHOLESTEROL
• Type of Device: CHOLESTEROL (TOTAL) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8577179
• MDR Text Key: 143958267
• Report Number: 1823260-2019-01667
• Device Sequence Number: 1
• Product Code: CHH
• Combination Product (y/n): N
• PMA/PMN Number: K051376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 11418262171
• Device Lot Number: 34902402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRUM A TO ZINCE; GO CHOLESTEROL SHIELD; LIFE EXTENSION NEURO-MAG; LIFE EXTENSION OMEGA 3; CENTRUM A TO ZINCE; GO CHOLESTEROL SHIELD; LIFE EXTENSION NEURO-MAG; LIFE EXTENSION OMEGA 3