MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® INFORM II TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number 05942861001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of discrepant glucose results for 1 neonate patient tested on inform ii meter (b)(4) (meter a) with test strip lot 476354 and inform ii meter (b)(4) (meter b) with test strip lot 476358.This medwatch will cover strip lot 476358.Refer to medwatch patient identifier (b)(6) for information on test strip lot 476354.All the results listed are from heel sticks.The patient was tested at 5:09 a.M.On meter a and the result was 43 mg/dl.The patient was retested at 5:17 a.M.On the same meter and the result was 61 mg/dl.The patient was tested at 8:03 a.M.On meter b and the result was 46 mg/dl.The patient was retested at 8:04 a.M.On the same meter and the result was 49 mg/dl.The patient was tested at 11:24 a.M.On meter b and the result was 20 mg/dl.The patient was retested at 11:26 a.M.On the same meter and the result was 27 mg/dl.Since the glucose results were so low and because they suspected chorioamnionitis due to a fever greater than 100.4 f, the patient was sent to the nicu.The patient is on hypoglycemic protocol.The nurses didn't think the patient's glucose was really as low as 20 mg/dl.The patient was tested on a 3rd inform ii meter (meter c) at 11:38 a.M.And the result was 46 mg/dl.This result was believed to be correct.The patient was fed breast milk due to the results from the meters.No adverse event occurred due to feeding the baby breast milk.The patient's glucose results have increased and stabilized.The following results were provided to demonstrate this: at 3:05 p.M.The patient was tested on meter c and the result was 37 mg/dl.At 4:50 p.M.The patient was tested on a 4th inform ii meter (meter d) and the result was 58 mg/dl.At 8:02 p.M.The patient was tested on meter d and the result was 60 mg/dl.At 11:16 p.M.The patient was tested on meter d and the result was 63 mg/dl.None of these additional results were being questioned.Both meters and test strips were requested for investigation.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

Manufacturer Narrative

The meters and test strips were requested for investigation.Two meters was returned, but the test strips were not returned.Retention strip lot 476358 was tested on the returned meter uu14215106 (meter a) with quality controls: control ranges: level 1 30-60 mg/dl, level 2 261-353 mg/dl.Results: level 1 ¿ 43, 41, 41 mg/dl , level 2 ¿ 286, 308, 307 mg/dl.Retention strip lot 476358 was tested on the returned meter uu14166107 (meter b) with quality controls: control ranges: level 1 30-60 mg/dl, level 2 261-353 mg/dl.Results: level 1 ¿ 41, 41, 42 mg/dl , level 2 ¿ 287, 308, 308 mg/dl.All returned results are within acceptable range.The investigation was unable to find a definitive root cause for this event.

• Brand Name: ACCU-CHEK ® INFORM II TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7581670
• MDR Text Key: 110946718
• Report Number: 1823260-2018-01791
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 05942861001
• Device Lot Number: 476358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3