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

Catalog Number 05942861001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 11/03/2015

Event Type  Injury  

Event Description

A patient was tested on (b)(6) 2015 at 6:06 pm on inform ii meter (serial number (b)(4)) and received a result of 235 mg/dl with no symptoms. On the morning of (b)(6) 2015, the caller stated that the patient was feeling low symptoms of stomach pain. They were tested on the same meter at 6:19 am and a result of rr lo was obtained. Rr lo is an alarm set by the institution for results that are below their defined reportable range threshold but are within the system measurement range of 10 mg/dl to 600 mg/dl. The reportable range for the facility is 20 mg/dl to 600 mg/dl. The nurse testing the patient interpreted the results of rr lo to be a high blood sugar , however, the alarm was notifying them that the results were actually below the institution's defined reportable range. It was further reported that the nurse did not treat the patient with d50 as she should of have based on the result. She tested the patient again at 6:20 am and at 6:33 am with a result of rr lo on the same meter. The nurse then tested the patient on a second inform ii meter (serial number (b)(4)) at 6:49am. The result at that time was also rr lo. The nurse gave the patient 10 units of novolog as treatment since she had misinterpreted the previous results of rr lo to mean the patient's blood glucose was high. The patient symptoms of stomach pain and shaking became worse. The patient did not lose consciousness. The nurse then tested the patient again on inform ii meter (serial number (b)(4)) at 6:54 am and received a result of lo. Lo indicates the blood glucose is below 10 mg/dl. At that point the nurse gave the patient d50. The patient was tested again at 7:02am on this meter and obtained a result of 271 mg/dl. The patient's symptoms improved after they were given the d50. The patient is currently doing okay. All of the results were obtained using strips from the same vial of strips. The suspect product was requested to be returned, however, the customer no longer has the vial of strips that were used for the aforementioned tests.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5323349
• MDR Text Key: 34249247
• Report Number: 1823260-2015-06116
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 05942861001
• Device Lot Number: 474130
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 12/23/2015 Patient Sequence Number: 1