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

Catalog Number 11418262171

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

Quality control results were acceptable.The customer¿s strips were requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.The investigation did not identify a product problem.The cause of the event could not be determined.The event occurred in: (b)(6).

Event Description

The initial reporter complained of a questionable cholesterol result from an accutrend plus meter serial number (b)(4) compared to an unspecified laboratory method.The initial cholesterol result from the meter was low.A "low" alarm means the result was below the measurement range.The measurement range for cholesterol is 3.88 - 7.76 mmol/l.The laboratory result was 7 mmol/l.The result in question was reported outside of the laboratory.

Manufacturer Narrative

The customer's meter and strips were returned for investigation.The returned product was measured in comparison to a reference meter and retention lot strips.Customer samples cholesterol lot 349024-04 and retention samples cholesterol lot 349024-04 were measured with controls level low /high lot 403614-01 on customer accutrend plus devices and reference devices.Low control measurements: testing results (qc range: 163 - 207 mg/dl): customer meter: qc 1: 195.0 mg/dl, qc 2: 188.1 mg/dl, qc 3: 193.9 mg/dl.Reference meter: qc 1: 193.0 mg/dl, qc 2: 181.0 mg/dl, qc 3: 188.0 mg/dl high control measurements: testing results (qc range: 224 - 284 mg/dl): customer meter: qc 1: 246.1 mg/dl, qc 2: 257.0 mg/dl, qc 3: 248.8 mg/dl.Reference meter: qc 1: 251.0 mg/dl, qc 2: 260.0 mg/dl, qc 3: 268.0 mg/dl.All results were within the control range.The results of all measurements fulfilled the requirements.No significant differences could be identified between the customer samples /customer meter and reference devices/ retention samples.

• 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: 8846998
• MDR Text Key: 152930780
• Report Number: 1823260-2019-02791
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 11418262171
• Device Lot Number: 34902404
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1