MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK SOFTCLIX; BLOOD LANCET

Catalog Number	07313462001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The softclix device was requested for investigation and replacement product was sent.The lancets used are no longer available for return.Product labeling for error 5 states "error 5: error applying blood to the test strip.Turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.Occupation: patient/consumer - the reporter is the patient's wife.
Event or Problem Description
We received an allegation that the coaguchek xs softclix lancing device may have contributed to a bacterial infection of the patient's ring finger.The patient's wife initially called due to a persistent error 5 from the coaguchek xs meter.Error 5 is related to an issue applying blood to the test strip.The call agent reviewed what causes error 5.The patient's wife stated the channel on the test strip was not getting completely filled with blood.The patient was not ready to test again at the time of the call.During the call, the patient's wife mentioned that the patient experienced pain and swelling in the ring finger (the specific part was not provided) he had used to puncture for testing.The patient reportedly got an infection on his ring finger after he punctured it and used it for testing.The patient reportedly went to the emergency room and was diagnosed with a bacterial infection.The patient reportedly received antibiotic treatment for the infection.The patient's wife confirmed there was no lancet protruding out and that there was no lancet broken in the finger.The patient's wife stated that the patient felt like something was stuck in the finger.An x-ray and computerized tomography (cat) scan reportedly revealed there were no objects lodged in the finger.This mdr is being submitted with an abundance of caution.
Additional Manufacturer Narrative
The lancet device was returned for investigation.The reported failure could not be confirmed during the investigation.The lancing device was in a functional condition.The lancing device was tested with some test lancets (lot u21a8) at 11 different pricking depth settings, for each attempt the needle was correctly retracted, ejected, and produced a puncture hole.The lancing device could be primed and released without any problems and works in accordance with specifications.The lancing device was disassembled for investigation, but no abnormalities could be observed which could verify the customer's allegation.The investigation did not identify a product problem.Medwatch fields d9 and h3 were updated.
Additional Manufacturer Narrative
In mfr report ref #1823260-2022-04236-00, b5 - describe event or problem should have been: "we received an allegation that the coaguchek xs softclix lancing device may have contributed to a bacterial infection of the patient's ring finger.The patient¿s wife initially called on (b)(6) 2022 due to an alleged persistent error 5 from the coaguchek xs meter.The call agent reviewed what causes error 5.The patient's wife stated the channel on the test strip was not getting completely filled with blood.The patient was not ready to test again at the time of the call.During the call, the patient's wife mentioned that the patient experienced pain and swelling in the ring finger (the specific part was not provided) he had used to puncture for testing on (b)(6) 2022.The patient reportedly got an infection on his ring finger after he punctured it and used it for testing.The patient reportedly went to the emergency room and was diagnosed with a bacterial infection.The patient reportedly received antibiotic treatment for the infection.The patient's wife confirmed there was no lancet protruding out and that there was no lancet broken in the finger.The patient's wife stated that the patient felt like something was stuck in the finger.An x-ray and computerized tomography (cat) scan reportedly revealed there were no objects lodged in the finger." instead of: "we received an allegation that the coaguchek xs softclix lancing device may have contributed to a bacterial infection of the patient's ring finger.The patient's wife initially called due to a persistent error 5 from the coaguchek xs meter.Error 5 is related to an issue applying blood to the test strip.The call agent reviewed what causes error 5.The patient's wife stated the channel on the test strip was not getting completely filled with blood.The patient was not ready to test again at the time of the call.During the call, the patient's wife mentioned that the patient experienced pain and swelling in the ring finger (the specific part was not provided) he had used to puncture for testing.The patient reportedly got an infection on his ring finger after he punctured it and used it for testing.The patient reportedly went to the emergency room and was diagnosed with a bacterial infection.The patient reportedly received antibiotic treatment for the infection.The patient's wife confirmed there was no lancet protruding out and that there was no lancet broken in the finger.The patient's wife stated that the patient felt like something was stuck in the finger.An x-ray and computerized tomography (cat) scan reportedly revealed there were no objects lodged in the finger." clarification was received that the patient was prescribed cephalexin 500mg, every 8 hours for 7 days.The patient was also instructed to apply neosporin as a topical treatment.A follow-up report will be submitted when the softclix device is returned.Medwatch fields g1 and h4 were updated.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): BALDA MEDICAL GMBH & CO.; kg bergkichener str. 228; na; bad oeynhausen 32549 ; GM 32549
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16072337
• Report Number: 1823260-2022-04236
• Device Sequence Number: 20406924
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 07313462001
• Device Lot Number: BBI052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 03/06/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/23/2023; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LISINOPRIL; METOPROLOL; PANTOPRAZOLE; SIMVASTATIN; SPIROMIDE; WARFARIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male