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

Catalog Number 05942861001

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable glucose results from accu-chek inform ii meters.At 16:44, the result from meter serial number (b)(4) was 512 mg/dl and was obtained from the left index finger.At 16:46, the result from meter serial number (b)(4) was 346 mg/dl and was obtained from the left index finger.At 16:49, the result from meter serial number (b)(4) was 109 mg/dl and was obtained from the left index finger.At 16:50, the result from meter serial number (b)(4) was 171 mg/dl.At 17:24, the result from a siemens dimension exl analyzer was 123 mg/dl.The nurse reported that the patient was eating fruit with her fingers.Treatment was provided based on the laboratory result.

Manufacturer Narrative

Quality controls were performed every 24 hours and passed.The customer returned >12 strips.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration.The returned vial hinge on the flip-top cap was partially broken off.On a regular basis, accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The investigation is ongoing.

Manufacturer Narrative

All testing with the returned strips produced acceptable results and no strip defects were observed.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15926694
• MDR Text Key: 307661311
• Report Number: 1823260-2022-03909
• Device Sequence Number: 1
• Product Code: LFR
• UDI-Device Identifier: 10365702428109
• UDI-Public: 00365702428102
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 05942861001
• Device Lot Number: 670203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• 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
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN TABLET.; ALBUTEROL INHALER.; AMIODARONE TABLET.; AQUAPHOR.; ASPIRIN EC TABLET DR.; ATORVASTATIN TABLET.; AZITHROMYCIN IV.; CARVEDILOL TABLET.; CIPROFLOXACIN TABLET.; DEXTROSE 50% INJECTION 7.5-25 G INSULIN.; DOCUSATE CAPSULE.; ENOXAPARIN SODIUM INJECTION.; FLUTICASONE-SALMETEROL 250-50 MCG/ACT INHALER.; GLUCOSE40%ORAL GEL 1-2 TUBE INSULIN.; INSULIN LISPRO INJECTION.; IRON POLYSACCHARIDES CAPSULE.; IV LASIX.; IV VENOFER.; LEVAQUIN.; LEVOTHYROXINE TABLET.; LISINOPRIL TABLET.; MAGNESIUM OXIDE TABLET.; MELATONIN TABLET.; METFORMIN TABLET.; ONDANSETRON DISINTEGRATING TABLET.; PANTORAZOLE TABLET.; POLYETHYLENE GLYCOL PACKET.; SODIUM CHLORIDE FLUSH 0.9% INJECTION.; ZOSYN.
• Patient Age: 78 YR
• Patient Sex: Female